21 Senior Pharmaceutical Regulatory Affairs Specialist Remote jobs in whatjobs

Senior Pharmaceutical Regulatory Affairs Specialist (Remote)

40100 Kisumu KES310000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a dynamic and innovative pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote global regulatory team. This critical position involves ensuring compliance with all national and international regulatory requirements for drug development, approval, and post-market surveillance. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing expert guidance on regulatory strategies. The ideal candidate possesses a deep understanding of pharmaceutical regulations, excellent analytical skills, and a proven ability to navigate complex regulatory landscapes. This is an exceptional opportunity to contribute to bringing life-saving medicines to market while working remotely.

Key Responsibilities:
  • Develop and execute global regulatory strategies for pharmaceutical product development and lifecycle management.
  • Prepare, review, and submit regulatory documentation (e.g., INDs, NDAs, MAAs, CTAs) to health authorities worldwide.
  • Serve as the primary point of contact for regulatory agencies, responding to queries and managing submissions.
  • Monitor and interpret evolving regulatory guidelines, legislation, and trends impacting the pharmaceutical industry.
  • Assess regulatory requirements for new product development, clinical trials, and post-approval changes.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
  • Ensure company compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP).
  • Manage and maintain regulatory databases and documentation systems.
  • Participate in regulatory audits and inspections.
  • Contribute to the development and improvement of internal regulatory processes and SOPs.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or Ph.D. is a plus.
  • Minimum of 7 years of experience in pharmaceutical regulatory affairs.
  • Proven experience in preparing and submitting regulatory dossiers to major health authorities (e.g., FDA, EMA, MHRA).
  • In-depth knowledge of pharmaceutical development processes, regulatory pathways, and global compliance requirements.
  • Excellent understanding of ICH guidelines and other relevant international regulatory standards.
  • Strong analytical, critical thinking, and problem-solving skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
  • Experience working effectively in a fully remote, collaborative team environment.
  • Detail-oriented with strong organizational and project management abilities.
  • Experience in specific therapeutic areas is an advantage.
This is a crucial remote role shaping the regulatory path for essential medicines, supporting our client's groundbreaking work in **Kisumu, Kisumu, KE**. Accelerate pharmaceutical innovation from anywhere.
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Senior Pharmaceutical Regulatory Affairs Specialist - Remote

50200 Tuwan KES175000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a pioneering pharmaceutical company dedicated to developing life-changing therapies, is seeking a highly skilled Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote global team. This critical role involves navigating the complex landscape of pharmaceutical regulations to ensure timely approval and ongoing compliance for the company's innovative products. You will be responsible for preparing and submitting regulatory dossiers, interpreting regulatory guidelines, and liaising with health authorities worldwide. The ideal candidate will possess extensive knowledge of global regulatory requirements, a sharp analytical mind, and exceptional communication skills to effectively advocate for the company's submissions. This position requires meticulous attention to detail and a passion for ensuring patient access to safe and effective medicines, managed entirely remotely.

Responsibilities:
  • Prepare, review, and submit high-quality regulatory dossiers for new drug applications (NDAs), variations, and renewals.
  • Interpret and advise on global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
  • Serve as the primary point of contact with regulatory agencies, managing communications and submissions.
  • Develop and implement regulatory strategies to support product development and commercialization.
  • Conduct regulatory intelligence activities to stay informed of evolving regulations and competitor landscape.
  • Ensure compliance with all applicable regulations and company policies throughout the product lifecycle.
  • Collaborate closely with R&D, clinical, manufacturing, and quality assurance teams.
  • Manage post-approval regulatory commitments and life-cycle management activities.
  • Lead regulatory interactions, including meetings and teleconferences with health authorities.
  • Mentor and guide junior regulatory affairs professionals.

Qualifications:
  • Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of regulatory submission processes and guidelines in major markets (e.g., US, EU, Canada, Japan).
  • Proven experience in preparing and managing various types of regulatory submissions.
  • Strong understanding of drug development processes, GMP, GCP, and GLP.
  • Excellent analytical, problem-solving, and strategic thinking skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
  • Demonstrated ability to work independently, manage multiple complex projects, and meet strict deadlines in a remote setting.
  • Proficiency in regulatory information management systems is a plus.
  • Strong interpersonal skills and the ability to work effectively in a global, cross-functional team.

This is a significant opportunity for an experienced regulatory affairs professional to contribute to groundbreaking pharmaceutical advancements, working remotely and impacting global health, with a specific focus on regulatory pathways relevant to the pharmaceutical landscape around Bungoma, Bungoma, KE .
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Senior Pharmaceutical Regulatory Affairs Specialist (Remote)

90100 Gathiruini KES155000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly motivated and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This is a fully remote position, offering the opportunity to contribute to groundbreaking drug development and market access from your home office.

The ideal candidate will possess a deep understanding of global pharmaceutical regulations, including submission requirements for various health authorities (e.g., FDA, EMA, PPB). You will be responsible for developing regulatory strategies, preparing and submitting regulatory dossiers, and ensuring compliance throughout the product lifecycle. This role requires exceptional attention to detail, strong analytical skills, and the ability to navigate complex regulatory landscapes.

Key responsibilities include:
  • Developing and implementing comprehensive regulatory affairs strategies for drug development and lifecycle management.
  • Preparing, reviewing, and submitting regulatory applications and dossiers to health authorities worldwide.
  • Ensuring all regulatory activities and submissions are in compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
  • Interfacing with regulatory agencies, responding to queries, and managing communications throughout the submission and approval process.
  • Monitoring changes in global regulatory requirements and assessing their impact on the company's products and strategies.
  • Collaborating with R&D, clinical, manufacturing, and commercial teams to provide regulatory guidance and support.
  • Managing post-approval regulatory activities, including annual reports and variations.
  • Conducting regulatory intelligence gathering and analysis.
  • Reviewing promotional materials for regulatory compliance.
  • Participating in regulatory audits and inspections.
  • Developing and maintaining strong relationships with key regulatory stakeholders.
  • Mentoring junior regulatory affairs professionals.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 5-7 years of experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions and approvals.
  • In-depth knowledge of international regulatory guidelines and submission requirements (e.g., ICH, FDA, EMA).
  • Familiarity with drug development processes and lifecycles.
  • Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
  • Strong analytical, problem-solving, and organizational skills.
  • Ability to work independently and manage multiple projects in a remote environment.
  • Proficiency in regulatory information management systems and standard office software.
  • Experience with both generic and innovative drug products is a plus.
This is an exciting opportunity for a dedicated regulatory affairs professional to contribute to the advancement of life-saving therapies. Join our client and be part of a mission-driven team, driving regulatory excellence from anywhere.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist (Remote)

00100 Abothuguchi West KES350000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a dynamic and rapidly growing pharmaceutical company, is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join our fully remote team. This critical role will involve managing all aspects of regulatory compliance and submissions for our diverse portfolio of pharmaceutical products. You will be responsible for interpreting and applying complex regulatory guidelines, preparing submission dossiers, and liaising with health authorities globally. The ideal candidate possesses a deep understanding of drug development processes, pharmaceutical manufacturing, and the global regulatory landscape. You will play a key role in ensuring that our products meet all required standards for safety, efficacy, and quality, enabling timely market access. Your expertise will be vital in navigating the intricacies of regulatory submissions, from initial planning through to approval. This is a remote-first position, requiring excellent communication skills, strong organizational abilities, and the capacity to work independently and collaboratively with cross-functional teams. You will work closely with R&D, Quality Assurance, Clinical Affairs, and Commercial teams to ensure regulatory strategies align with business objectives. A proven track record of successful regulatory submissions and approvals in major markets is essential. You will be expected to stay current with evolving regulatory requirements and provide strategic guidance on regulatory policy. This role offers an exciting opportunity to make a significant impact on patient access to essential medicines and contribute to the company's global expansion. We are looking for a dedicated professional with a meticulous approach, strong attention to detail, and a passion for ensuring the highest standards of pharmaceutical regulatory compliance.

Key Responsibilities:
  • Develop and implement regulatory strategies for new and existing pharmaceutical products.
  • Prepare, review, and submit regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, Kenya NRB).
  • Serve as the primary point of contact with regulatory agencies during submission processes.
  • Interpret and communicate complex regulatory requirements and guidance documents to internal stakeholders.
  • Ensure compliance with all applicable pharmaceutical regulations, guidelines, and standards.
  • Collaborate with R&D, Quality, Clinical, and Manufacturing teams to gather necessary information for submissions.
  • Manage post-approval regulatory activities, including amendments, supplements, and renewals.
  • Conduct regulatory intelligence activities to stay updated on global regulatory trends and changes.
  • Provide regulatory input and support for product development, lifecycle management, and marketing activities.
  • Assess the regulatory impact of proposed product changes and manufacturing processes.
  • Develop and deliver regulatory training to internal teams.
  • Participate in regulatory inspections and audits.
  • Contribute to the continuous improvement of regulatory processes and systems.
  • Evaluate and advise on the regulatory feasibility of new business development opportunities.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or relevant professional certification (e.g., RAC) is highly desirable.
  • Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
  • Proven experience with global regulatory submissions (e.g., NDAs, ANDAs, MAAs).
  • In-depth knowledge of ICH guidelines and regional regulatory requirements (e.g., US, EU, Africa).
  • Strong understanding of drug development, manufacturing, and quality systems.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Outstanding written and verbal communication skills, with the ability to present complex information clearly.
  • Exceptional organizational and project management skills.
  • Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote setting.
  • Proficiency in regulatory information management systems and databases.
  • High ethical standards and a commitment to compliance.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist - Remote

00200 Ongata Rongai, Rift Valley KES470000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a rapidly growing pharmaceutical company dedicated to advancing global health, is actively seeking an accomplished Senior Pharmaceutical Regulatory Affairs Specialist to join their innovative and fully remote team. This role is pivotal in ensuring our client's products meet all necessary regulatory standards and gain timely approval in target markets worldwide. The ideal candidate will possess extensive knowledge of global pharmaceutical regulations, including FDA, EMA, and other key international health authorities. You will be responsible for preparing, submitting, and managing regulatory dossiers for new drug applications, variations, and renewals. Key duties include interpreting regulatory guidelines, developing regulatory strategies, and liaising with regulatory agencies to facilitate smooth approval processes. This position demands meticulous attention to detail, strong analytical skills, and the ability to navigate complex regulatory landscapes effectively. You will collaborate closely with R&D, clinical operations, quality assurance, and manufacturing teams, requiring excellent communication and project management skills in a virtual setting. The Senior Pharmaceutical Regulatory Affairs Specialist will stay abreast of evolving regulatory requirements and provide expert guidance to internal stakeholders. Experience in post-market surveillance, pharmacovigilance reporting, and lifecycle management of pharmaceutical products is highly advantageous. This remote role offers a unique opportunity to impact patient access to critical medicines by ensuring compliance and facilitating approvals on a global scale, requiring a high level of self-motivation and organizational prowess.

Responsibilities:
  • Develop and execute global regulatory strategies for pharmaceutical products.
  • Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities.
  • Serve as a key point of contact for regulatory agencies worldwide.
  • Interpret and advise on regulatory requirements and guidelines.
  • Manage regulatory submissions throughout their lifecycle, including post-approval changes.
  • Collaborate with internal departments (R&D, QA, Manufacturing, Clinical) to ensure regulatory compliance.
  • Monitor regulatory intelligence and industry trends, communicating impact to the organization.
  • Provide guidance on labeling, advertising, and promotional materials.
  • Contribute to regulatory aspects of due diligence for potential acquisitions or partnerships.
  • Maintain regulatory compliance for marketed products.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 6 years of experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of ICH guidelines and major regulatory agency requirements (FDA, EMA, etc.).
  • Proven experience in preparing and submitting major regulatory applications.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Strong project management and organizational abilities, particularly in a remote context.
  • Superior written and verbal communication skills for effective stakeholder interaction.
  • Ability to work independently and as part of a distributed global team.
  • Experience with electronic submission systems and regulatory information management (RIM) software.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist - Remote

80100 Nairobi, Nairobi KES190000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a highly respected pharmaceutical company committed to advancing global health, is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This pivotal role involves ensuring that all company products comply with national and international regulatory requirements throughout their lifecycle, from development to post-market surveillance. You will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities, responding to regulatory inquiries, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess in-depth knowledge of pharmaceutical regulations, guidelines, and submission processes. Your responsibilities will include developing regulatory strategies, advising R&D teams on regulatory compliance, and managing the regulatory aspects of product registrations and approvals. Strong analytical skills, meticulous attention to detail, and excellent written and verbal communication are essential for success in this position. You will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Commercial departments, to facilitate timely market access for innovative therapies. This fully remote role requires a self-motivated and organized professional capable of managing multiple projects and deadlines independently. You will play a critical role in bringing life-saving and life-enhancing medications to patients worldwide, contributing significantly to the company's mission while enjoying the flexibility of a remote work environment. The ability to interpret complex regulatory requirements and translate them into practical, actionable guidance for the organization is paramount.
Responsibilities:
  • Develop and implement global regulatory strategies for product development and lifecycle management.
  • Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
  • Serve as the primary regulatory contact for assigned projects and products.
  • Respond to questions and requests from regulatory agencies.
  • Monitor and interpret evolving regulatory guidelines and legislation impacting the pharmaceutical industry.
  • Provide regulatory guidance and support to R&D, Quality, and Commercial teams.
  • Assess the regulatory impact of proposed changes to product manufacturing, labeling, and marketing.
  • Ensure compliance with all applicable GMP, GCP, and GLP regulations.
  • Manage post-approval regulatory activities, including supplements and variations.
  • Maintain regulatory documentation and databases.
  • Contribute to the continuous improvement of regulatory processes and systems.
Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline; Master's degree or Pharm.D. is a plus.
  • Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
  • Comprehensive knowledge of global regulatory submission requirements and guidelines (e.g., FDA, EMA, ICH).
  • Proven experience in preparing and submitting major regulatory filings.
  • Excellent understanding of drug development processes and pharmaceutical manufacturing.
  • Strong analytical, problem-solving, and strategic thinking skills.
  • Exceptional written and verbal communication skills, with a high degree of accuracy.
  • Ability to work independently and manage multiple priorities in a remote setting.
  • Detail-oriented with strong organizational skills.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist (Remote)

60101 Embu, Eastern KES260000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This critical role will be responsible for ensuring compliance with all relevant pharmaceutical regulations, guiding the development and submission of regulatory filings, and maintaining positive relationships with health authorities.

Key Responsibilities:
  • Develop and implement regulatory strategies for product development, registration, and lifecycle management.
  • Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities in various global markets.
  • Interpret and advise on complex regulatory requirements, guidelines, and legislation impacting pharmaceutical products.
  • Liaise directly with regulatory agencies (e.g., KEBS, FDA, EMA) to facilitate the approval process and address inquiries.
  • Ensure that all company activities and products comply with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
  • Manage post-approval regulatory activities, including variations, renewals, and annual reports.
  • Conduct regulatory intelligence gathering to stay abreast of emerging trends and changes in the regulatory landscape.
  • Collaborate with cross-functional teams (R&D, Clinical, Manufacturing, Quality Assurance) to provide regulatory input and support.
  • Assess the regulatory implications of product changes, manufacturing processes, and labeling.
  • Contribute to the development and implementation of departmental SOPs and policies.

Qualifications:
  • Minimum of 8 years of experience in pharmaceutical regulatory affairs.
  • Proven experience in preparing and submitting successful regulatory submissions for various product types.
  • In-depth knowledge of global pharmaceutical regulations and guidelines (e.g., ICH, FDA, EMA, KEBS).
  • Strong understanding of drug development processes, manufacturing, and quality systems.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication skills, with a talent for concise and accurate documentation.
  • Ability to manage multiple projects simultaneously and meet strict deadlines.
  • Experience working in a remote or virtual team environment is highly desirable.
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or Pharm.D. is preferred.
  • Proficiency in regulatory information management systems.
This fully remote role is vital for our operations based out of Embu, Embu, KE and requires a dedicated and meticulous professional.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Regulatory Affairs Specialist - Remote

20200 Abothuguchi West KES7000000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a dynamic and growing pharmaceutical company, is seeking a highly skilled Senior Pharmaceutical Regulatory Affairs Specialist to join their global team. This is a critical, fully remote role requiring extensive knowledge of international pharmaceutical regulations and submission processes. You will be responsible for ensuring compliance and facilitating the approval of pharmaceutical products in various global markets, all from your home office. The ideal candidate is detail-oriented, possesses excellent strategic thinking, and thrives in a remote, fast-paced environment.

Responsibilities:
  • Develop and execute global regulatory strategies for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and variations.
  • Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, eCTD) to health authorities worldwide.
  • Serve as a key point of contact with regulatory agencies, responding to inquiries and addressing deficiencies.
  • Monitor and interpret global regulatory guidelines and provide strategic advice to internal teams.
  • Conduct regulatory intelligence activities to stay abreast of emerging trends and requirements.
  • Collaborate with cross-functional teams (e.g., R&D, Clinical, Manufacturing, Quality Assurance) to ensure regulatory compliance throughout the product lifecycle.
  • Manage post-approval regulatory activities, including annual reports, supplements, and labeling changes.
  • Review promotional and advertising materials for regulatory compliance.
  • Contribute to the development of regulatory policies and procedures.
  • Lead and mentor junior regulatory affairs professionals.
  • Ensure timely communication of regulatory updates and potential risks to stakeholders.
  • Support regulatory due diligence for business development activities.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
  • Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, Japan).
  • In-depth knowledge of ICH guidelines, CTD/eCTD format, and specific regional regulatory requirements.
  • Strong analytical, problem-solving, and strategic planning skills.
  • Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
  • Experience working independently and managing multiple complex projects in a remote setting.
  • Proficiency with regulatory information management (RIM) systems and eCTD publishing software.
  • Ability to build effective working relationships with regulatory agencies and internal stakeholders.
  • High level of integrity and attention to detail.
This remote position offers the chance to significantly influence global product approvals and shape regulatory strategy for innovative medicines. Join a forward-thinking organization committed to improving patient access to therapies.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist - Remote

71100 Gathiruini KES130000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a leading pharmaceutical entity, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their entirely remote team. This critical role involves ensuring compliance with all relevant pharmaceutical regulations and guidelines for product development, manufacturing, and marketing. The ideal candidate will possess a deep understanding of regulatory processes, excellent analytical skills, and the ability to navigate complex regulatory landscapes. This position offers the flexibility of remote work, with a strategic focus on the **Mlolongo, Machakos, KE** pharmaceutical hub and surrounding areas.

Key Responsibilities:
  • Develop and execute regulatory strategies for product registration and lifecycle management in target markets.
  • Prepare, review, and submit regulatory documentation (e.g., dossiers, applications, amendments) to health authorities.
  • Interpret and apply national and international pharmaceutical regulations, guidelines, and standards.
  • Liaise with regulatory agencies to facilitate product approvals and address regulatory inquiries.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
  • Conduct regulatory intelligence activities to stay informed about evolving regulatory requirements and industry trends.
  • Assess the regulatory implications of product changes, manufacturing processes, and labeling updates.
  • Manage post-approval regulatory obligations and ensure ongoing compliance.
  • Participate in regulatory audits and inspections, both internal and external.
  • Contribute to the development and implementation of regulatory affairs policies and procedures.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, 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 pharmaceutical regulatory frameworks (e.g., ICH, FDA, EMA guidelines) and local Kenyan regulations.
  • Strong understanding of drug development processes, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
  • Proficiency in regulatory information management systems and electronic submission tools.
  • Ability to work independently, manage multiple projects, and meet tight deadlines in a remote environment.
  • Strong negotiation and influencing skills when interacting with health authorities.

This remote opportunity provides a challenging and rewarding career path for a seasoned regulatory professional eager to impact pharmaceutical accessibility and compliance within the **Mlolongo, Machakos, KE** region and beyond.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist (Remote)

30200 Tuwan KES290000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a prestigious pharmaceutical company committed to advancing global health, is actively seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This is a fully remote position, offering the flexibility to work from your preferred location while playing a crucial role in ensuring compliance and market access for vital pharmaceutical products. The successful candidate will be responsible for navigating complex regulatory landscapes, preparing and submitting regulatory dossiers, and maintaining strong relationships with health authorities. You will provide expert guidance on regulatory requirements, ensuring that all product development and manufacturing activities adhere to national and international guidelines. This role requires a meticulous attention to detail, a thorough understanding of drug development processes, and a proactive approach to regulatory strategy. You will work closely with cross-functional teams, including R&D, clinical affairs, quality assurance, and manufacturing, to ensure seamless regulatory submissions and approvals. This is an exceptional opportunity to contribute to life-changing medicines and advance your career in a remote-first, collaborative environment. Your expertise will be critical in bringing innovative treatments to patients worldwide, supporting regulatory activities that impact products potentially used by populations near **Kitale, Trans-Nzoia, KE**. Key responsibilities include:
  • Developing and implementing regulatory strategies for new and existing pharmaceutical products.
  • Preparing, reviewing, and submitting regulatory dossiers (e.g., CTD, IND, NDA) to health authorities globally.
  • Interpreting and advising on relevant pharmaceutical regulations, guidelines, and standards.
  • Managing regulatory lifecycle activities, including post-approval changes and renewals.
  • Liaising with regulatory agencies, responding to inquiries, and facilitating meetings.
  • Conducting regulatory intelligence activities to stay informed about evolving requirements.
  • Providing regulatory support for product development, manufacturing, and marketing.
  • Ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
  • Reviewing promotional materials for regulatory compliance.

Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. A Master's or PhD is a plus.
  • Minimum of 6 years of experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of global regulatory submission processes and requirements (e.g., FDA, EMA, WHO).
  • Proven experience in preparing and submitting various types of regulatory dossiers.
  • Familiarity with pharmaceutical product development, manufacturing, and quality systems.
  • Strong understanding of relevant scientific principles and regulatory guidelines.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Ability to manage multiple projects, prioritize tasks, and meet tight deadlines in a remote setting.
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