1,810 Pharmaceuticals jobs in Kenya
Senior Process Engineer - Pharmaceuticals
80200 Shella
KES170000 Annually
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Posted 3 days ago
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Job Description
Our client, a leading entity in the manufacturing sector, is seeking a highly skilled Senior Process Engineer with specialized experience in pharmaceuticals to join their innovative and fully remote team. This role is integral to optimizing and scaling up pharmaceutical manufacturing processes, ensuring efficiency, quality, and compliance with stringent industry standards. As a Senior Process Engineer, you will be responsible for designing, developing, and troubleshooting complex manufacturing processes, from R&D through to full-scale production. You will leverage your deep technical knowledge to improve yields, reduce waste, and enhance product quality. This position is a remote-first opportunity, providing you with the flexibility to contribute your expertise from your chosen location within Kenya.
The ideal candidate will possess a thorough understanding of pharmaceutical manufacturing principles, including Good Manufacturing Practices (GMP), validation, and regulatory requirements. You should have proven experience with process scale-up, technology transfer, and process automation. Your responsibilities will include conducting process simulations, performing root cause analysis for production issues, and implementing corrective and preventive actions (CAPA). You will also play a key role in the design and commissioning of new equipment and facilities. This role requires strong analytical, problem-solving, and project management skills, as well as excellent communication and interpersonal abilities to collaborate effectively with cross-functional teams, including R&D, quality assurance, and operations. We are looking for a forward-thinking individual committed to driving innovation and operational excellence in pharmaceutical manufacturing. If you are passionate about applying chemical engineering principles to pharmaceutical production in a remote setting, this is an exceptional opportunity. This role is associated with our operations near Malindi, Kilifi, KE , but is fully remote.
Responsibilities:
The ideal candidate will possess a thorough understanding of pharmaceutical manufacturing principles, including Good Manufacturing Practices (GMP), validation, and regulatory requirements. You should have proven experience with process scale-up, technology transfer, and process automation. Your responsibilities will include conducting process simulations, performing root cause analysis for production issues, and implementing corrective and preventive actions (CAPA). You will also play a key role in the design and commissioning of new equipment and facilities. This role requires strong analytical, problem-solving, and project management skills, as well as excellent communication and interpersonal abilities to collaborate effectively with cross-functional teams, including R&D, quality assurance, and operations. We are looking for a forward-thinking individual committed to driving innovation and operational excellence in pharmaceutical manufacturing. If you are passionate about applying chemical engineering principles to pharmaceutical production in a remote setting, this is an exceptional opportunity. This role is associated with our operations near Malindi, Kilifi, KE , but is fully remote.
Responsibilities:
- Design, develop, and optimize pharmaceutical manufacturing processes.
- Lead process scale-up activities from laboratory to commercial production.
- Ensure compliance with GMP, FDA, and other regulatory standards.
- Develop and execute process validation protocols.
- Troubleshoot process deviations and implement effective CAPAs.
- Conduct process hazard analyses (PHAs) and risk assessments.
- Specify, evaluate, and commission new process equipment.
- Implement process automation and control strategies.
- Collaborate with R&D, QA/QC, and manufacturing teams.
- Prepare technical documentation, including PFDs, P&IDs, and batch records.
- Mentor junior engineers and share technical expertise.
- Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field; Master's degree preferred.
- Minimum of 7 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of pharmaceutical manufacturing processes (e.g., sterile manufacturing, API synthesis, formulation).
- Strong understanding of GMP, validation principles, and regulatory requirements.
- Proficiency in process simulation and modeling software.
- Experience with process automation and control systems (e.g., DCS, SCADA).
- Excellent analytical, problem-solving, and project management skills.
- Strong written and verbal communication skills.
- Ability to work effectively in a remote team environment.
- Experience with technology transfer and plant commissioning is a plus.
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0
Senior Formulation Scientist - Pharmaceuticals
20119 Mwembe
KES220000 Annually
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Posted 7 days ago
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Job Description
Our client is a leading pharmaceutical company seeking a highly motivated and experienced Senior Formulation Scientist to join their innovative research and development team on a fully remote basis. This critical role will focus on the design, development, and optimization of novel pharmaceutical dosage forms for a diverse range of therapeutic areas. You will leverage your deep understanding of pre-formulation, formulation development, and manufacturing processes to bring new medicines to patients efficiently and effectively. The ideal candidate will possess extensive experience with various dosage forms, including oral solids, liquids, injectables, and topical preparations. Responsibilities include conducting pre-formulation studies, identifying and characterizing excipients, developing robust formulation strategies, and optimizing drug delivery systems. You will be responsible for overseeing laboratory-scale formulation development, troubleshooting formulation challenges, and conducting stability studies to ensure product quality and shelf-life. Experience with process development, scale-up, and technology transfer to manufacturing is essential. This role requires a strong understanding of pharmaceutical regulations (e.g., FDA, EMA) and Good Manufacturing Practices (GMP). You will collaborate closely with analytical development, regulatory affairs, and manufacturing teams to ensure seamless project progression. The ability to interpret complex scientific data, author comprehensive technical reports, and present findings to cross-functional teams is crucial. This position offers a unique opportunity to contribute to cutting-edge pharmaceutical innovation within a supportive and collaborative remote environment. We are looking for a scientifically curious, detail-oriented, and results-driven individual with a passion for drug development.
Key Responsibilities:
Key Responsibilities:
- Design and develop innovative pharmaceutical formulations for various dosage forms (e.g., oral solids, liquids, injectables, topicals).
- Conduct comprehensive pre-formulation studies, including solubility, stability, and compatibility assessments.
- Characterize and select appropriate excipients to achieve desired drug product performance.
- Optimize formulation processes to ensure consistent product quality and manufacturability.
- Oversee laboratory-scale formulation development and pilot batch production.
- Troubleshoot formulation challenges and develop effective solutions.
- Design and execute stability studies according to ICH guidelines.
- Develop and document formulation processes, analytical methods, and technical reports.
- Collaborate with analytical development, regulatory affairs, and manufacturing departments.
- Ensure all development activities comply with relevant pharmaceutical regulations and GMP guidelines.
- Stay abreast of emerging technologies and industry trends in pharmaceutical formulation.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical formulation development.
- Proven track record in developing a variety of dosage forms, with expertise in at least one specific area (e.g., sterile injectables, controlled-release oral solids).
- In-depth knowledge of pre-formulation science, excipient functionality, and drug delivery systems.
- Experience with process development, scale-up, and technology transfer.
- Strong understanding of pharmaceutical regulatory requirements (e.g., FDA, EMA) and GMP.
- Proficiency in data analysis, interpretation, and technical writing.
- Excellent problem-solving skills and attention to detail.
- Ability to work independently and collaboratively in a remote team environment.
- Strong communication and presentation skills.
This advertiser has chosen not to accept applicants from your region.
1
Lead Formulation Scientist - Pharmaceuticals
00100 Gathiruini
KES580000 Annually
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Posted 7 days ago
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Job Description
Our client, a dynamic and forward-thinking pharmaceutical company, is seeking an experienced and innovative Lead Formulation Scientist to join their fully remote research and development team. This senior-level position plays a crucial role in the development of novel pharmaceutical formulations, from concept to clinical supply. The ideal candidate will possess a deep understanding of drug delivery systems, formulation science, and regulatory requirements, coupled with strong leadership capabilities.
As the Lead Formulation Scientist, you will be responsible for guiding and executing formulation development strategies for a diverse portfolio of pharmaceutical products. This includes designing and conducting pre-formulation studies, developing robust and stable dosage forms (e.g., oral solid doses, injectables, topicals), and optimizing formulation processes. You will oversee the scale-up of laboratory formulations to pilot and commercial manufacturing scales, ensuring successful technology transfer. A key aspect of this role involves troubleshooting formulation challenges, identifying root causes, and implementing effective solutions. You will also be responsible for authoring and reviewing relevant sections of regulatory submission documents (e.g., IND, NDA). Leading and mentoring a team of formulation scientists, fostering a collaborative and innovative research environment, will be essential. You will collaborate closely with analytical development, DMPK, and clinical teams to ensure alignment and timely project progression.
We require a Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical Engineering, or a closely related field, with a minimum of 8 years of progressive experience in pharmaceutical formulation development. Demonstrated experience in leading formulation projects and a strong track record of successful product development and regulatory submissions are mandatory. Expertise in various dosage forms and delivery technologies is essential. Excellent understanding of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., ICH) is required. Exceptional problem-solving, analytical, and critical thinking skills are necessary. Outstanding communication, interpersonal, and leadership skills are crucial for managing a remote team and collaborating effectively with cross-functional partners. This is an exceptional opportunity to make a significant impact on drug development from a remote position supporting our operations near **Mlolongo, Machakos, KE**.
As the Lead Formulation Scientist, you will be responsible for guiding and executing formulation development strategies for a diverse portfolio of pharmaceutical products. This includes designing and conducting pre-formulation studies, developing robust and stable dosage forms (e.g., oral solid doses, injectables, topicals), and optimizing formulation processes. You will oversee the scale-up of laboratory formulations to pilot and commercial manufacturing scales, ensuring successful technology transfer. A key aspect of this role involves troubleshooting formulation challenges, identifying root causes, and implementing effective solutions. You will also be responsible for authoring and reviewing relevant sections of regulatory submission documents (e.g., IND, NDA). Leading and mentoring a team of formulation scientists, fostering a collaborative and innovative research environment, will be essential. You will collaborate closely with analytical development, DMPK, and clinical teams to ensure alignment and timely project progression.
We require a Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical Engineering, or a closely related field, with a minimum of 8 years of progressive experience in pharmaceutical formulation development. Demonstrated experience in leading formulation projects and a strong track record of successful product development and regulatory submissions are mandatory. Expertise in various dosage forms and delivery technologies is essential. Excellent understanding of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., ICH) is required. Exceptional problem-solving, analytical, and critical thinking skills are necessary. Outstanding communication, interpersonal, and leadership skills are crucial for managing a remote team and collaborating effectively with cross-functional partners. This is an exceptional opportunity to make a significant impact on drug development from a remote position supporting our operations near **Mlolongo, Machakos, KE**.
This advertiser has chosen not to accept applicants from your region.
2
Senior Purchasing Manager - Pharmaceuticals
10100 Nyeri Town
KES1100000 Annually
WhatJobs
Posted 7 days ago
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Job Description
Our client, a prominent player in the pharmaceutical supply chain, is actively seeking a seasoned Senior Purchasing Manager to lead their procurement operations. This is a critical, fully remote role, allowing the successful candidate to manage procurement strategies and supplier relationships from anywhere. You will be responsible for developing and implementing effective purchasing strategies for raw materials, active pharmaceutical ingredients (APIs), and other essential supplies. This involves identifying and vetting new suppliers, negotiating favorable terms and contracts, and ensuring a consistent and reliable supply chain. You will manage inventory levels, optimize procurement processes, and drive cost-saving initiatives without compromising quality. A deep understanding of the pharmaceutical market, including global sourcing, regulatory requirements (e.g., GMP, FDA standards), and quality assurance for pharmaceutical-grade materials, is essential. You will also be responsible for forecasting demand, managing budgets, and mitigating supply chain risks. Strong analytical, problem-solving, and leadership skills are paramount. The ability to build and maintain strong relationships with key stakeholders, both internal and external, is crucial. Experience with procurement software and a proven track record of success in managing complex procurement operations within the pharmaceutical industry is required. This is an exceptional opportunity to make a significant impact on supply chain efficiency and cost-effectiveness for a leading organization, all while enjoying the flexibility of a remote role. Our client is committed to fostering a collaborative and results-oriented work environment. The ideal geographic focus for this role, considering market access, is around **Nyeri, Nyeri, KE**. We are looking for strategic thinkers with a passion for optimizing supply chains in the pharmaceutical sector.
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist - Pharmaceuticals
50200 Tuwan
KES7000000 Annually
WhatJobs
Posted 4 days ago
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Job Description
Our client is a rapidly growing pharmaceutical company seeking a highly competent and detail-oriented Senior Regulatory Affairs Specialist to join their international team. This is a fully remote position, offering an exceptional opportunity to contribute to the global drug development and approval process from your home office. You will be responsible for developing and executing regulatory strategies for product registration and lifecycle management in various target markets. This includes preparing and submitting regulatory dossiers (e.g., CTD, IND, NDA), liaising with health authorities, and ensuring compliance with global regulatory requirements and guidelines. Your expertise will be crucial in navigating complex regulatory landscapes and facilitating the timely market access of our innovative pharmaceutical products. The ideal candidate will possess a strong understanding of pharmaceutical product development, manufacturing, and quality assurance processes.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and registration.
- Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Serve as the primary point of contact for regulatory agencies, managing communications and responses.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Interpret and apply relevant regulatory guidelines and legislation.
- Manage the regulatory aspects of product lifecycle management, including post-approval changes and renewals.
- Conduct regulatory intelligence activities to stay abreast of evolving requirements and competitor activities.
- Review labeling, promotional materials, and advertising for regulatory compliance.
- Contribute to the development of regulatory policies and procedures.
- Ensure adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) where applicable.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- A minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
- Proven experience in preparing and submitting successful regulatory dossiers to major health authorities (e.g., FDA, EMA, PMDA).
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines (e.g., ICH).
- Strong understanding of drug development processes, clinical trials, and pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with a strong ability to write clear and concise regulatory documents.
- Proficiency in regulatory information management systems and common office software.
- Ability to work independently, manage multiple projects simultaneously, and meet demanding deadlines in a remote setting.
- Experience with biosimilars or biologics is a plus.
This advertiser has chosen not to accept applicants from your region.
4
Senior Quality Assurance Specialist - Pharmaceuticals
30200 Tuwan
KES170000 Annually
WhatJobs
Posted 5 days ago
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Job Description
Our client, a reputable pharmaceutical company, is seeking a highly detail-oriented and experienced Senior Quality Assurance Specialist to join their fully remote quality team. This role is integral to ensuring that all pharmaceutical products meet stringent quality standards and regulatory compliance requirements. As a remote-first position, you will conduct comprehensive quality assessments, develop and implement quality management systems, and contribute to continuous improvement initiatives from your dedicated home office. You will work closely with manufacturing, R&D, and regulatory affairs departments, providing crucial oversight and guidance. The ideal candidate will possess in-depth knowledge of pharmaceutical quality regulations (e.g., GMP, ICH guidelines), strong analytical skills, and a proven ability to manage quality-related projects effectively in a remote setting.
Key Responsibilities:
Qualifications:
This is a fully remote opportunity. The conceptual oversight for this role is directed towards operations around Kitale, Trans-Nzoia, KE .
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with regulatory standards.
- Conduct internal audits and assessments of manufacturing processes, documentation, and systems to ensure adherence to GMP and other relevant guidelines.
- Review and approve batch records, validation protocols, and change control documents.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in external audits and inspections by regulatory authorities (e.g., FDA, EMA, NCCA).
- Develop and deliver quality training programs to relevant personnel.
- Monitor and report on key quality metrics and performance indicators.
- Contribute to the qualification and validation of equipment and processes.
- Collaborate with R&D and manufacturing teams to ensure quality is integrated throughout the product lifecycle.
- Stay updated on evolving pharmaceutical quality regulations and industry best practices.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- A Master's degree or advanced certification in Quality Assurance is a plus.
- Minimum of 6 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant ICH guidelines.
- Proven experience in conducting audits, managing CAPAs, and handling regulatory inspections.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent attention to detail and accuracy.
- Proficiency in quality management software and tools.
- Exceptional written and verbal communication skills, with the ability to effectively communicate complex quality issues.
- Ability to work independently and manage workload effectively in a remote environment.
This is a fully remote opportunity. The conceptual oversight for this role is directed towards operations around Kitale, Trans-Nzoia, KE .
This advertiser has chosen not to accept applicants from your region.
5
Senior Formulation Scientist - Pharmaceuticals (Remote)
00200 Ngong
KES225000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and innovative Senior Formulation Scientist to join their leading-edge, fully remote Pharmaceutical Development team. This crucial role is responsible for the design, development, optimization, and scale-up of innovative pharmaceutical dosage forms. You will leverage your deep expertise in pharmaceutics, drug delivery systems, and solid-state chemistry to create robust and effective drug products. The ideal candidate possesses a strong track record in developing various dosage forms (e.g., tablets, capsules, injectables, topical formulations) and a thorough understanding of excipient science, material characterization, and manufacturing processes. You will collaborate extensively with analytical development, CMC, regulatory affairs, and manufacturing teams to ensure seamless project progression from early-stage research to commercialization. This position requires exceptional scientific rigor, meticulous experimental design, strong analytical capabilities, and excellent problem-solving skills. You will be instrumental in troubleshooting formulation challenges, driving innovation in drug delivery, and ensuring compliance with stringent regulatory standards within a remote work framework. We seek an individual passionate about translating scientific discoveries into tangible pharmaceutical products.
A Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related field is required. A minimum of 7 years of progressive experience in pharmaceutical formulation development is essential. Hands-on experience with a variety of dosage forms and delivery systems is mandatory. Proficiency in drug product characterization techniques (e.g., DSC, TGA, XRPD, dissolution testing) is required. Strong understanding of cGMP and regulatory requirements for drug product development is crucial. Excellent analytical, problem-solving, and project management skills are paramount. Exceptional verbal and written communication abilities are necessary for effective remote collaboration and reporting. Experience within the pharmaceutical industry in or around the **Ruiru, Kiambu, KE** region, or a similar pharmaceutical hub, would be advantageous, but the fully remote nature of this position enables global recruitment. Join our client and shape the future of pharmaceutical innovation from your home office.
- Design and develop novel pharmaceutical formulations for various therapeutic areas.
- Conduct pre-formulation studies, including API characterization and compatibility studies.
- Select and optimize excipients to achieve desired drug product performance and stability.
- Develop and validate analytical methods for assessing drug product quality.
- Execute formulation development experiments using laboratory-scale equipment.
- Plan and oversee pilot-scale batches and scale-up activities.
- Troubleshoot formulation-related issues and implement corrective actions.
- Prepare comprehensive development reports and contribute to regulatory filings (e.g., IND, NDA).
- Stay updated on the latest advancements in pharmaceutics, drug delivery technologies, and regulatory guidelines.
- Collaborate with external partners and contract manufacturing organizations (CMOs).
- Ensure adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Provide technical guidance and mentorship to junior formulation scientists.
- Conduct literature reviews and patent searches related to formulation development.
- Evaluate new technologies and equipment for formulation and characterization.
A Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related field is required. A minimum of 7 years of progressive experience in pharmaceutical formulation development is essential. Hands-on experience with a variety of dosage forms and delivery systems is mandatory. Proficiency in drug product characterization techniques (e.g., DSC, TGA, XRPD, dissolution testing) is required. Strong understanding of cGMP and regulatory requirements for drug product development is crucial. Excellent analytical, problem-solving, and project management skills are paramount. Exceptional verbal and written communication abilities are necessary for effective remote collaboration and reporting. Experience within the pharmaceutical industry in or around the **Ruiru, Kiambu, KE** region, or a similar pharmaceutical hub, would be advantageous, but the fully remote nature of this position enables global recruitment. Join our client and shape the future of pharmaceutical innovation from your home office.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Regulatory Affairs Specialist - Pharmaceuticals
00200 Ongata Rongai, Rift Valley
KES350000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and experienced Senior Regulatory Affairs Specialist to join their fully remote pharmaceutical team. This role is critical for ensuring that our client's pharmaceutical products comply with all relevant national and international regulations. You will be responsible for preparing and submitting regulatory filings, maintaining regulatory documentation, and staying current with evolving regulatory landscapes. The ideal candidate will have a deep understanding of the drug development and approval process, with a strong focus on regulatory strategy. You will work closely with R&D, quality assurance, and commercial teams to provide expert guidance on regulatory requirements throughout the product lifecycle. This position requires meticulous attention to detail, excellent analytical skills, and the ability to manage multiple complex projects simultaneously. As a remote position, you must possess excellent communication skills and the ability to collaborate effectively with a dispersed team. We are looking for a proactive individual who can anticipate regulatory challenges and develop effective solutions. This is an excellent opportunity to contribute to the development and commercialization of innovative medicines while working in a flexible, remote environment. The successful candidate will play a key role in bringing life-saving and life-enhancing therapies to market. Your expertise will be vital in navigating the intricacies of pharmaceutical regulations. The role supports our client's operations, with a key focus on the region around Ongata Rongai, Kajiado, KE . Join a dedicated team committed to excellence in pharmaceutical regulation from the convenience of your home office.Responsibilities:
- Prepare and submit regulatory dossiers for new drug applications (NDAs) and variations.
- Ensure compliance with all applicable local and international pharmaceutical regulations.
- Maintain up-to-date knowledge of regulatory guidelines and agency requirements.
- Liaise with regulatory authorities on submissions and inquiries.
- Develop and implement regulatory strategies for product development and commercialization.
- Review and approve labeling, promotional materials, and advertising for regulatory compliance.
- Provide regulatory guidance to R&D, clinical, quality, and marketing teams.
- Manage post-approval regulatory activities, including annual reports and supplements.
- Conduct regulatory intelligence activities and assess impact on current and future products.
- Oversee the maintenance of regulatory documentation and databases.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 5-7 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory filings (e.g., NDAs, CTAs).
- In-depth knowledge of pharmaceutical regulatory requirements and guidelines (e.g., FDA, EMA, KEBS).
- Excellent analytical, problem-solving, and project management skills.
- Strong written and verbal communication abilities.
- Ability to work independently and manage projects effectively in a remote setting.
- Experience with specific therapeutic areas is a plus.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Specialist - Pharmaceuticals
01200 Gathiruini
KES130000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company committed to advancing global health, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their fully remote team. This critical role will focus on ensuring compliance with regulatory requirements for pharmaceutical product development, registration, and lifecycle management, all while working from your home base in **Mlolongo, Machakos, KE**. The ideal candidate will possess an in-depth understanding of global regulatory landscapes, including FDA, EMA, and other key health authority requirements. You will be responsible for preparing, submitting, and maintaining regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and variations. Your role will involve advising project teams on regulatory strategies, assessing the regulatory impact of proposed changes, and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). We are looking for a candidate with a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field, and a minimum of 6 years of progressive experience in pharmaceutical regulatory affairs. A Master's degree or Pharm.D. is a significant advantage. Proven experience in successfully navigating complex regulatory submissions and maintaining product registrations is essential. Exceptional attention to detail, strong analytical and communication skills, and the ability to manage multiple complex projects simultaneously in a remote setting are paramount. If you are a dedicated regulatory affairs professional looking for a challenging and impactful remote opportunity to contribute to bringing life-saving medications to market, we encourage you to apply.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, MAA) to health authorities.
- Manage post-approval regulatory activities, including variations and lifecycle management.
- Liaise with health authorities to facilitate the regulatory review process.
- Advise R&D, clinical, and manufacturing teams on regulatory requirements and strategy.
- Assess the regulatory impact of product changes and deviations.
- Ensure compliance with relevant pharmaceutical regulations and guidelines (GMP, GCP, GVP).
- Monitor regulatory intelligence and advise on evolving global requirements.
- Maintain regulatory documentation and databases.
- Contribute to regulatory inspections and audits.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science. Master's degree or Pharm.D. is preferred.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH, etc.).
- Proven experience in preparing and submitting various regulatory filings.
- Strong understanding of pharmaceutical product development and lifecycle management.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills.
- Ability to manage multiple projects effectively and meet tight deadlines in a remote environment.
- Detail-oriented with a strong commitment to compliance and quality.
This advertiser has chosen not to accept applicants from your region.
8
Senior Regulatory Affairs Specialist, Pharmaceuticals
30100 Tuwan
KES140000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is seeking a highly qualified Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This role is critical for ensuring that our client's pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. You will be responsible for preparing, submitting, and managing regulatory documentation for new drug applications, variations, and renewals, as well as interacting with regulatory agencies. The ideal candidate possesses a deep understanding of pharmaceutical regulations, a meticulous approach to documentation, and excellent communication skills.
Key Responsibilities:
Qualifications:
This is a key role for ensuring our client's market access and compliance. If you are a dedicated regulatory affairs professional seeking a challenging and rewarding remote opportunity, we encourage you to apply.
Key Responsibilities:
- Prepare and submit high-quality regulatory submissions (e.g., CTD, NDA, ANDA, variations, renewals) to health authorities in target markets.
- Maintain a thorough understanding of current and evolving regulatory requirements in relevant jurisdictions.
- Manage the regulatory lifecycle of assigned products, ensuring ongoing compliance.
- Liaise with regulatory agencies during the review process, responding to queries and providing necessary information.
- Develop and implement regulatory strategies to support product development and commercialization goals.
- Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
- Conduct regulatory intelligence activities to identify new opportunities and potential risks.
- Collaborate with internal teams (R&D, Clinical, Quality, Manufacturing) to gather information and ensure alignment on regulatory strategies.
- Assess the regulatory impact of manufacturing changes, quality deviations, and clinical trial results.
- Maintain regulatory databases and ensure accurate record-keeping.
- Provide regulatory guidance and training to internal stakeholders.
- Participate in due diligence activities for potential acquisitions or partnerships.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience in preparing and submitting diverse regulatory dossiers to various health authorities.
- In-depth knowledge of global pharmaceutical regulatory guidelines (e.g., ICH, FDA, EMA, WHO).
- Experience with both prescription drugs and OTC products is desirable.
- Strong understanding of drug development, manufacturing processes, and quality assurance.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Exceptional attention to detail and organizational skills.
- Ability to work independently, manage multiple projects, and meet strict deadlines in a remote environment.
- Proficiency in regulatory information management systems and standard office software.
- Experience in specific therapeutic areas is a plus.
This is a key role for ensuring our client's market access and compliance. If you are a dedicated regulatory affairs professional seeking a challenging and rewarding remote opportunity, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.
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