15 Regulatory Affairs Specialist jobs in Kenya
Senior Regulatory Affairs Specialist
70100 Gathiruini
KES140000 Annually
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Our client is seeking a highly experienced Senior Regulatory Affairs Specialist to navigate and ensure compliance with complex legal and regulatory landscapes. This is a fully remote position, offering the flexibility to manage critical regulatory functions from any location. The successful candidate will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory documentation, and ensuring adherence to all applicable laws and guidelines. You will play a vital role in liaising with regulatory authorities and advising internal teams on regulatory requirements and changes. Key responsibilities include monitoring regulatory developments, assessing their impact on the company's operations, and developing strategies to ensure compliance. You will also be involved in the review of marketing materials, product labeling, and promotional activities to ensure they meet regulatory standards. This role demands a profound understanding of regulatory affairs principles, particularly within the company's industry. The ideal candidate will possess exceptional analytical, research, and communication skills, with a keen eye for detail and accuracy. Experience in managing complex regulatory submissions and a strong track record of successful interactions with regulatory bodies are essential. You will work collaboratively with cross-functional teams, including R&D, manufacturing, marketing, and legal, to ensure seamless integration of regulatory requirements throughout the product lifecycle. Our client values a proactive and strategic approach to regulatory compliance, and this role is instrumental in safeguarding the company's operations and reputation. The designated geographical context for this role, despite its remote nature, is **Mlolongo, Machakos, KE**, aligning with our client's operational reach and regulatory engagement in the region.
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Senior Pharmaceutical Regulatory Affairs Specialist
00200 Ngong
KES70000 Monthly
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Posted 1 day ago
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Our client is seeking a detail-oriented and knowledgeable Senior Pharmaceutical Regulatory Affairs Specialist to ensure compliance with all applicable pharmaceutical regulations and guidelines. This fully remote position is vital for navigating the complex regulatory landscape and securing product approvals and market access. You will be responsible for preparing, submitting, and managing regulatory filings, liaising with health authorities, and providing regulatory expertise to cross-functional teams. The ideal candidate will possess a strong understanding of drug development processes, extensive knowledge of global regulatory requirements, and excellent communication and documentation skills. Key Responsibilities:
- Prepare and submit regulatory dossiers (e.g., CTD, NDA, ANDA) for new drug applications and variations.
- Manage post-approval regulatory activities, including amendments, renewals, and lifecycle management.
- Liaise with regulatory agencies (e.g., Pharmacy and Poisons Board, FDA, EMA) on submissions, inquiries, and inspections.
- Interpret and communicate regulatory requirements to internal stakeholders, including R&D, manufacturing, and marketing teams.
- Develop and implement regulatory strategies to support product development and commercialization goals.
- Review labeling, promotional materials, and advertising for regulatory compliance.
- Monitor regulatory changes and assess their impact on the company's products and operations.
- Maintain regulatory databases and ensure accurate record-keeping.
- Participate in cross-functional teams to provide regulatory input and guidance.
- Contribute to the development of regulatory intelligence and compliance policies.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or relevant certification is a plus.
- Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission requirements and guidelines in key markets (e.g., Kenya, US, EU).
- Proven experience in preparing and submitting regulatory dossiers and managing regulatory agency interactions.
- Strong understanding of pharmaceutical product development, manufacturing, and quality control.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a talent for clear and concise documentation.
- Meticulous attention to detail and strong organizational abilities.
- Proficiency in regulatory information management systems.
- Ability to work independently and manage priorities effectively in a remote setting.
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Senior Pharmaceutical Regulatory Affairs Specialist
00232 Ngong
KES170000 Annually
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Posted 2 days ago
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Join a leading pharmaceutical company as a Senior Pharmaceutical Regulatory Affairs Specialist, working in a fully remote capacity. Our client is at the forefront of developing innovative medicines and therapies, and they are seeking a meticulous and experienced professional to ensure compliance with global regulatory standards. This role is critical for guiding drug development and marketing authorization processes. You will be responsible for interpreting and applying complex regulatory guidelines, preparing and submitting regulatory dossiers, and liaising with health authorities worldwide. The ideal candidate will possess a strong scientific background, a comprehensive understanding of pharmaceutical regulations (e.g., FDA, EMA), and a proven track record of successful regulatory submissions. Exceptional attention to detail, strategic thinking, and excellent written and verbal communication skills are essential. As this is a remote position, you must be highly organized, self-motivated, and adept at collaborating effectively with cross-functional teams virtually. Your responsibilities will include developing regulatory strategies, managing post-approval changes, and staying current with evolving regulatory landscapes. We are looking for an individual who is passionate about patient access to life-saving medicines and can navigate the intricate world of pharmaceutical regulation with expertise. This is an outstanding opportunity to contribute to groundbreaking advancements in healthcare from the convenience of your home office. A Master's or Ph.D. in Pharmacy, Life Sciences, or a related field, along with a minimum of 6 years of relevant experience in pharmaceutical regulatory affairs, is required.
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2
Senior Pharmaceutical Regulatory Affairs Specialist
20117 Mwembe
KES125000 Annually
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Posted 2 days ago
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Our client, a progressive pharmaceutical company dedicated to advancing healthcare, is seeking a Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote position. This role is integral to ensuring compliance with global regulatory requirements for pharmaceutical products. The Specialist will be responsible for preparing, reviewing, and submitting regulatory documentation for drug registration and post-approval changes in various international markets. You will stay abreast of evolving regulatory landscapes, interpret complex regulations, and provide strategic guidance to cross-functional teams, including R&D, manufacturing, and marketing. Key responsibilities include managing regulatory submissions (e.g., INDs, NDAs, MAAs), responding to regulatory agency inquiries, and ensuring adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). The ideal candidate will possess a strong scientific background, extensive knowledge of pharmaceutical regulatory affairs, and a meticulous attention to detail. This fully remote role demands excellent organizational, communication, and project management skills. The ability to work independently, manage multiple priorities, and collaborate effectively with remote teams and global regulatory agencies is essential. We are looking for a seasoned professional with a proven track record in navigating the complexities of pharmaceutical regulations and a commitment to ensuring product safety and efficacy. This is a significant opportunity to contribute to bringing life-saving medications to market within a flexible, remote work setting. The primary reference location for this role is Naivasha, Nakuru, KE , with the work performed entirely remotely.
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3
Remote Pharmaceutical Regulatory Affairs Specialist
50200 Tuwan
KES3500000 Annually
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Posted 2 days ago
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Our client is seeking a highly skilled and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist to provide expert guidance on regulatory compliance and strategy for drug development and commercialization. This position operates entirely remotely, requiring a proactive individual with a deep understanding of global pharmaceutical regulations and a proven ability to navigate complex regulatory landscapes.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a seasoned regulatory affairs professional to contribute significantly to drug development from a remote location, ideally based near Bungoma, Bungoma, KE , but open to candidates globally.
Key Responsibilities:
- Develop, manage, and execute regulatory strategies for product registration and lifecycle management in various international markets.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities such as FDA, EMA, and others.
- Ensure compliance with all applicable regulatory guidelines, laws, and agency requirements throughout the product development and post-market phases.
- Liaise with regulatory agencies, participate in meetings, and respond to queries from health authorities.
- Interpret regulatory guidelines and provide strategic advice to internal teams (R&D, Clinical, Manufacturing, Marketing) to ensure compliance.
- Monitor changes in the regulatory environment and assess their impact on company strategies and operations.
- Conduct regulatory due diligence for potential partnerships, acquisitions, or in-licensing opportunities.
- Develop and maintain regulatory documentation and databases.
- Train and mentor junior regulatory affairs staff on regulatory requirements and best practices.
- Manage external regulatory consultants and vendors as needed.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. Advanced degree (Master's, Pharm.D., Ph.D.) is highly preferred.
- Minimum of 7 years of direct experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory requirements (FDA, EMA, ICH guidelines, etc.) for drug development and approval.
- Proven experience in preparing and submitting successful regulatory filings.
- Strong understanding of drug discovery, development, manufacturing, and quality assurance processes.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly and concisely.
- Experience working effectively in a remote, cross-functional team environment.
- Proficiency in regulatory information management (RIM) systems and document management systems.
- High level of integrity, attention to detail, and ability to manage multiple priorities under tight deadlines.
This is an exceptional opportunity for a seasoned regulatory affairs professional to contribute significantly to drug development from a remote location, ideally based near Bungoma, Bungoma, KE , but open to candidates globally.
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4
Remote Pharmaceutical Regulatory Affairs Specialist
10100 Nyeri Town
KES320000 Annually
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Posted 2 days ago
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Our client is a leading pharmaceutical company seeking a dedicated and detail-oriented Pharmaceutical Regulatory Affairs Specialist to join their team on a fully remote basis. This role is crucial for ensuring that all pharmaceutical products meet the stringent regulatory requirements of national and international health authorities. You will be responsible for preparing, reviewing, and submitting regulatory documentation, managing product registrations, and staying current with evolving regulatory landscapes. The ideal candidate will possess a strong understanding of pharmaceutical development, manufacturing processes, and global regulatory guidelines.
Responsibilities:
Qualifications:
Responsibilities:
- Prepare and submit regulatory submissions (e.g., INDs, NDAs, MAAs) to health authorities.
- Review and approve labeling, advertising, and promotional materials for regulatory compliance.
- Manage post-approval regulatory activities, including annual reports and lifecycle management.
- Interpret and apply regulatory guidelines and requirements to product development and commercialization.
- Communicate effectively with regulatory agencies to resolve queries and facilitate approvals.
- Conduct regulatory intelligence activities to stay informed about changes in the regulatory environment.
- Collaborate with R&D, quality assurance, manufacturing, and commercial teams to ensure regulatory compliance.
- Participate in regulatory strategy development for new and existing products.
- Develop and maintain regulatory databases and filing systems.
- Ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) related to regulatory submissions.
- Provide regulatory support for product development projects.
- Train internal stakeholders on regulatory requirements and processes.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or relevant certification is a plus.
- Minimum of 4-6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission requirements in key markets (e.g., US FDA, EMA, WHO).
- Experience with preparing and filing various types of regulatory dossiers.
- Familiarity with ICH guidelines and regional regulatory requirements.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proven ability to analyze complex scientific and regulatory information.
- Strong project management and organizational skills.
- Ability to work independently and as part of a remote team.
- Proficiency in regulatory information management systems.
- Experience in a specific therapeutic area is advantageous.
- Understanding of pharmaceutical development and manufacturing processes.
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5
Senior Pharmaceutical Regulatory Affairs Specialist
30200 Tuwan
KES110000 Annually
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Posted 4 days ago
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Job Description
Our client is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dynamic, fully remote team. This pivotal role involves navigating the complex landscape of pharmaceutical regulations to ensure compliance and facilitate the approval of new drug products and medical devices. You will be responsible for preparing, reviewing, and submitting regulatory documentation, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA), as well as variations and renewals. Your expertise will be crucial in interpreting and applying global regulatory guidelines (e.g., FDA, EMA, WHO) to product development strategies. This is a remote-first position, demanding exceptional organizational skills, meticulous attention to detail, and the ability to work autonomously while collaborating effectively with internal and external stakeholders across different time zones. You will liaise with health authorities, manage regulatory submission timelines, and provide strategic regulatory guidance to R&D, clinical, and commercial teams. The ideal candidate will possess a strong scientific background, a thorough understanding of the drug development lifecycle, and a proven track record of successful regulatory submissions. You will contribute to shaping regulatory strategies, ensuring that our client's innovative products reach patients efficiently and safely. The role requires staying abreast of evolving regulatory requirements and advising the company on potential impacts and opportunities. You will also play a key role in post-market regulatory activities, including lifecycle management and compliance monitoring. The ability to conduct regulatory intelligence gathering and competitor analysis will be advantageous. This position offers the opportunity to work on cutting-edge pharmaceutical projects and significantly contribute to global health.
Responsibilities:
Qualifications:
Responsibilities:
- Prepare, review, and submit regulatory dossiers (IND, NDA, ANDA, Variations) to health authorities worldwide.
- Interpret and apply global regulatory guidelines (FDA, EMA, WHO, etc.) to product development.
- Liaise with regulatory agencies and respond to queries.
- Provide strategic regulatory guidance throughout the product lifecycle.
- Manage regulatory submission timelines and ensure adherence to deadlines.
- Conduct regulatory intelligence and competitor analysis.
- Support post-market regulatory activities and lifecycle management.
- Collaborate with R&D, clinical, manufacturing, and quality assurance teams.
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Review and approve promotional materials for regulatory compliance.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory applications in major markets (US, EU).
- In-depth knowledge of drug development processes and regulatory requirements.
- Excellent understanding of ICH guidelines and global regulatory landscapes.
- Strong analytical, critical thinking, and problem-solving skills.
- Exceptional written and verbal communication skills for remote collaboration.
- Ability to manage multiple projects and prioritize tasks effectively.
- Proficiency in regulatory information management systems is a plus.
- High level of accuracy and attention to detail.
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6
Senior Pharmaceutical Regulatory Affairs Specialist - Remote
70100 Abothuguchi West
KES260000 Annually
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Posted 3 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dynamic and fully remote global team. This role is critical in ensuring that the company's products comply with all relevant regulations and guidelines in target markets, facilitating timely product approvals and maintaining compliance throughout the product lifecycle. The ideal candidate will possess a deep understanding of pharmaceutical regulations, a strong analytical ability, and the capacity to navigate complex regulatory landscapes independently. As this is a remote-first position, exceptional organizational skills and proactive communication are paramount.
Responsibilities:
Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Liaise with regulatory agencies (e.g., Pharmacy and Poisons Board of Kenya, FDA, EMA) to address inquiries and facilitate product approvals.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Monitor and interpret evolving regulatory landscapes and provide strategic advice to internal stakeholders.
- Conduct regulatory due diligence for potential partnerships and acquisitions.
- Manage post-approval regulatory activities, including variations, annual reports, and lifecycle management.
- Review and approve promotional materials and labeling to ensure regulatory compliance.
- Collaborate with R&D, manufacturing, marketing, and legal departments to support regulatory submissions and compliance.
- Maintain regulatory documentation and databases.
- Provide regulatory training and guidance to cross-functional teams.
- Assess the regulatory impact of product changes and market strategies.
- Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of international pharmaceutical regulations (e.g., ICH guidelines, FDA, EMA, PPB regulations).
- Experience working in a remote or global regulatory environment.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Strong written and verbal communication skills, with the ability to clearly articulate complex regulatory issues.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work independently, manage multiple projects, and meet tight deadlines.
- Experience in specific therapeutic areas is a plus.
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7
Senior Regulatory Affairs Specialist - API Development
30100 Abothuguchi West
KES700000 Annually
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Posted 4 days ago
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Job Description
Our client is actively seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to focus on Active Pharmaceutical Ingredient (API) development. This is a critical remote role that demands a comprehensive understanding of global pharmaceutical regulations and a proven ability to navigate complex submission processes. You will be responsible for developing and executing regulatory strategies, preparing and filing regulatory submissions (e.g., INDs, NDAs, DMFs), and ensuring compliance with relevant health authority guidelines worldwide. The ideal candidate will possess strong analytical skills, meticulous attention to detail, and the ability to collaborate effectively with cross-functional teams in a fully remote setting.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement global regulatory strategies for API development, manufacturing, and lifecycle management.
- Prepare, review, and file regulatory submissions, including Drug Master Files (DMFs), Investigational New Drug Applications (INDs), and New Drug Applications (NDAs), with various health authorities (e.g., FDA, EMA, PMDA).
- Interpret and apply global regulatory guidelines and requirements related to APIs and drug product development.
- Provide regulatory guidance and support to R&D, manufacturing, quality assurance, and other cross-functional teams.
- Assess the regulatory impact of changes in manufacturing processes, specifications, and analytical methods.
- Manage regulatory agency interactions, including responding to queries and preparing for inspections.
- Conduct regulatory intelligence activities to stay abreast of evolving regulations and guidelines.
- Review and approve labeling, promotional materials, and other regulatory-related documents.
- Develop and maintain regulatory documentation and databases.
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant quality standards.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degrees are a plus.
- Minimum of 6-8 years of experience in regulatory affairs within the pharmaceutical industry, with a strong emphasis on API development and submissions.
- In-depth knowledge of global regulatory requirements for APIs and drug products, including ICH guidelines.
- Proven experience in preparing and submitting DMFs, INDs, and NDAs.
- Familiarity with GMP regulations and quality systems.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
- Strong analytical and problem-solving abilities, with meticulous attention to detail.
- Experience working effectively in a remote, collaborative team environment.
- Ability to manage multiple projects and meet deadlines in a fast-paced setting.
- Proficiency in regulatory information management systems and common office software.
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8
Senior Regulatory Affairs Counsel
20110 Mwembe
KES240000 Annually
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Posted 1 day ago
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Job Description
Our client, a leading player in the pharmaceutical industry, is seeking an accomplished Senior Regulatory Affairs Counsel to lead their remote legal and compliance team. This critical role will ensure adherence to all applicable national and international regulatory requirements. The successful candidate will be responsible for providing expert legal advice on regulatory matters related to drug development, clinical trials, manufacturing, and marketing. This includes interpreting complex regulatory statutes and guidelines, advising on compliance strategies, and managing interactions with regulatory agencies. You will review and approve promotional materials, labeling, and scientific publications to ensure regulatory compliance. Developing and implementing robust compliance programs, conducting risk assessments, and providing training to internal stakeholders will be key responsibilities. The ideal candidate possesses a Juris Doctor (JD) or equivalent law degree from a reputable institution and is admitted to practice law. A strong understanding of pharmaceutical regulations (e.g., FDA, EMA) and a minimum of 6-8 years of experience in regulatory affairs law, preferably within the pharmaceutical or life sciences sector, are required. Experience with regulatory submissions, post-market surveillance, and compliance investigations is highly desirable. Excellent analytical, strategic thinking, and communication skills are essential for navigating complex regulatory landscapes and advising senior management. This role demands a meticulous, detail-oriented, and proactive individual who can effectively manage multiple priorities and work independently in a remote capacity. The ability to translate complex legal and regulatory requirements into practical business solutions is crucial. This is an exceptional opportunity to contribute to ensuring patient safety and market access for vital pharmaceutical products.
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