766 Senior Regulatory Affairs Specialist Pharmaceutical Remote jobs in Kenya
Senior Regulatory Affairs Specialist - Pharmaceuticals - Remote
Posted 10 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their globally distributed team. This is a crucial, fully remote position focused on ensuring compliance with pharmaceutical regulations across various international markets. You will be responsible for developing and executing regulatory strategies for product approvals, managing submissions, and maintaining regulatory compliance throughout the product lifecycle. Your expertise will guide the company through complex regulatory landscapes, ensuring timely market access for innovative therapies. Key responsibilities include preparing and submitting marketing authorization applications (MAAs), responding to regulatory agency queries, and staying abreast of evolving regulatory requirements. You will collaborate closely with R&D, clinical, manufacturing, and commercial teams to ensure regulatory alignment and success. The ideal candidate possesses a deep understanding of pharmaceutical regulations, strong analytical skills, and the ability to navigate diverse regulatory frameworks.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement global regulatory strategies for new drug applications and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD format) for marketing authorization applications (MAAs) in various regions.
- Serve as the primary liaison with regulatory authorities, responding to agency inquiries and facilitating communication.
- Ensure ongoing compliance with post-approval regulatory commitments and reporting requirements.
- Monitor and interpret changes in the global regulatory landscape and assess their impact on the company's product portfolio.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing.
- Evaluate regulatory risks and opportunities associated with product development and commercialization.
- Manage variations and amendments to approved marketing authorizations.
- Contribute to the development of regulatory policies and procedures.
- Conduct regulatory intelligence activities to identify emerging trends and competitor strategies.
- Mentor and train junior regulatory affairs professionals.
Qualifications:
- Master's degree or Ph.D. in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting MAAs in major markets (e.g., EMA, FDA, PPB).
- Thorough understanding of ICH guidelines and regional pharmaceutical regulatory requirements.
- Excellent scientific, analytical, and problem-solving skills.
- Exceptional written and verbal communication skills, with strong attention to detail.
- Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines.
- Proficiency in regulatory information management systems and electronic submission platforms.
- Strong interpersonal skills and the ability to collaborate effectively with internal teams and external stakeholders.
- Experience working effectively in a remote, international team environment.
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Senior Regulatory Affairs Specialist - Pharmaceutical - Remote
Posted 10 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a highly proficient Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This critical role will involve managing all aspects of regulatory submissions and ensuring compliance with national and international pharmaceutical regulations. You will be responsible for preparing, reviewing, and submitting regulatory dossiers for drug product registrations, variations, and renewals. This includes ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). You will liaise with regulatory authorities, health ministries, and other relevant agencies to facilitate timely approvals and address queries. The ideal candidate will possess a strong understanding of the drug development lifecycle and extensive experience with regulatory submission processes in key markets. Expertise in navigating the regulatory landscape for pharmaceuticals, biologics, and medical devices is essential. You will stay updated on evolving regulatory requirements and provide strategic guidance to internal teams, including R&D, manufacturing, and marketing. This position demands exceptional attention to detail, strong analytical skills, and the ability to manage complex projects independently. Excellent written and verbal communication skills are vital for clear and effective interaction with both internal stakeholders and external regulatory bodies. As a fully remote role, you will need to be self-motivated and organized, capable of working autonomously while maintaining collaborative relationships with colleagues. This is an excellent opportunity to contribute to bringing vital medicines to patients worldwide from the convenience of your home. The role supports strategic initiatives within **Thika, Kiambu, KE**, but is a remote position.
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Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is actively seeking a highly experienced and detail-oriented Lead Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, allowing you to contribute from any location in Kenya. You will be instrumental in ensuring our pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. This position demands a deep understanding of drug development, submission processes, and post-approval maintenance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to relevant health authorities.
- Monitor and interpret changes in pharmaceutical regulations and guidelines, providing proactive guidance to the organization.
- Liaise effectively with regulatory agencies, health authorities, and other stakeholders.
- Oversee the regulatory aspects of product lifecycle management, including variations, renewals, and amendments.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Provide regulatory input and support for product development, clinical trials, and marketing authorization applications.
- Manage regulatory documentation and databases, ensuring accuracy and completeness.
- Lead and mentor junior regulatory affairs professionals, fostering a collaborative and expert team environment.
- Conduct regulatory intelligence activities to stay abreast of evolving global regulatory landscapes.
Qualifications:
- Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, KEBS).
- Proven experience in preparing and submitting marketing authorization applications.
- Demonstrated experience managing regulatory submissions for various therapeutic areas.
- Excellent understanding of drug development processes and regulatory pathways.
- Strong analytical, problem-solving, and project management skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working in a remote or hybrid team setting is highly desirable.
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Principal Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading player in the pharmaceutical industry, is seeking an exceptionally experienced Principal Pharmaceutical Regulatory Affairs Specialist to join their globally distributed team. This is a fully remote position, offering the unique opportunity to work from your location within Kenya and significantly influence global regulatory strategies. You will be the primary point of contact for regulatory submissions and interactions with health authorities worldwide. Your expertise will guide the company through complex regulatory landscapes, ensuring compliance with international guidelines and standards. Key responsibilities include developing regulatory strategies for new drug applications (NDAs), variations, and lifecycle management; preparing and submitting high-quality dossiers to regulatory agencies; and assessing regulatory risks and opportunities. You will collaborate closely with R&D, clinical development, manufacturing, and commercial teams to ensure alignment between regulatory requirements and business objectives. The ideal candidate will have a profound understanding of pharmaceutical product development, a comprehensive knowledge of global regulatory requirements (FDA, EMA, WHO, etc.), and a proven track record of successful regulatory submissions and approvals. Excellent analytical, strategic thinking, and communication skills are paramount. As this is a remote role, you must be highly self-disciplined, proactive, and adept at managing complex projects and cross-functional teams virtually. While the company operates globally, this role supports strategic alignment that may impact operations or research initiatives related to **Embu, Embu, KE**, but your work will be entirely remote.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Serve as the primary liaison with regulatory agencies, responding to queries and managing submissions.
- Assess regulatory risks and provide strategic guidance to project teams.
- Interpret and apply global regulatory guidelines and advise on compliance matters.
- Collaborate with R&D, Clinical, CMC, and Commercial teams to ensure regulatory requirements are met.
- Monitor changes in the regulatory landscape and advise the organization on strategic implications.
- Lead regulatory due diligence activities for potential acquisitions or partnerships.
- Mentor and guide junior regulatory affairs professionals.
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Advanced degree (PharmD, PhD, MSc) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory requirements and submission processes (e.g., FDA, EMA, ICH).
- Proven track record of successful IND, NDA, and/or MAA submissions and approvals.
- Exceptional strategic thinking, analytical, and problem-solving skills.
- Outstanding written and verbal communication and presentation skills.
- Demonstrated leadership capabilities and experience managing complex projects.
- Ability to work effectively independently and in a virtual, cross-functional team environment.
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Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
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:
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.
- 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 advertiser has chosen not to accept applicants from your region.
4
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
Job Description
Our client is seeking a detail-oriented and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their dynamic team in a fully remote capacity. This vital role involves ensuring compliance with all relevant pharmaceutical regulations and guidelines throughout the product lifecycle, from development to post-market surveillance. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory agencies, and staying abreast of evolving regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical drug development, regulatory processes, and international regulatory frameworks. Key responsibilities include managing regulatory submissions (e.g., INDs, NDAs, MAAs), reviewing product labeling for compliance, assessing changes to approved products, and providing regulatory guidance to internal teams. You will also be involved in regulatory strategy development and risk assessment. Experience with specific therapeutic areas or drug classes is advantageous. This is an exceptional opportunity to make a significant contribution to patient access to safe and effective medicines, working from a remote environment with a leading pharmaceutical organization. You must possess excellent analytical, organizational, and communication skills, with a keen eye for detail. The ability to interpret complex regulations and apply them effectively to specific situations is crucial. A bachelor's or master's degree in a relevant scientific field (e.g., Pharmacy, Chemistry, Biology) is required. This role demands a proactive approach, the ability to work independently, and strong collaboration skills to work effectively with cross-functional teams. The conceptual work location is **Mlolongo, Machakos, KE**, but the position is performed entirely remotely.
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Principal Remote Pharmaceutical Regulatory Affairs Specialist
Posted 17 days ago
Job Viewed
Job Description
Our client is actively seeking a highly accomplished and strategic Principal Remote Pharmaceutical Regulatory Affairs Specialist to navigate the complex landscape of pharmaceutical regulations worldwide. This is a fully remote position, offering the flexibility to influence global regulatory strategies from your home office. The successful candidate will be responsible for developing and executing comprehensive regulatory affairs strategies for the company's pharmaceutical products. This involves preparing, reviewing, and submitting regulatory documentation to health authorities in various regions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). You will stay abreast of evolving global regulatory requirements, guidelines, and trends, ensuring the company remains compliant and competitive. A significant aspect of this role involves providing expert regulatory guidance to cross-functional teams, including R&D, clinical affairs, manufacturing, and marketing, to ensure alignment with regulatory objectives. You will manage regulatory submissions throughout their lifecycle, responding to queries from health authorities and facilitating product approvals. The Principal Specialist will also play a key role in assessing the regulatory implications of product development, post-market changes, and lifecycle management activities. This position requires a deep understanding of pharmaceutical sciences, drug development processes, and international regulatory frameworks. Exceptional analytical, problem-solving, and project management skills are essential. Strong written and verbal communication abilities are critical for effective interaction with regulatory agencies and internal stakeholders in a remote setting. The ability to lead and influence teams, manage multiple projects simultaneously, and work independently with a high degree of accuracy is paramount. Experience in dossier preparation using common technical document (CTD) formats and proficiency with regulatory information management systems are highly desirable. This is an exceptional opportunity to shape the regulatory path of innovative medicines and contribute significantly to global health initiatives, working remotely near Thika, Kiambu, KE .
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Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This fully remote role is crucial for navigating the complex regulatory landscape and ensuring compliance with global pharmaceutical standards. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and advising on regulatory strategies to support product development and market approval. The ideal candidate possesses a strong understanding of pharmaceutical regulations, meticulous attention to detail, and proven success in a remote work setting.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory dossiers for drug applications (e.g., IND, NDA, MAA) to relevant health authorities.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, local health authorities) to facilitate the review process and respond to queries.
- Develop and implement global regulatory strategies to support product development and lifecycle management.
- Monitor and interpret changes in regulatory requirements and provide timely updates and recommendations to internal teams.
- Assess the regulatory impact of product changes, manufacturing processes, and promotional materials.
- Collaborate closely with R&D, Quality Assurance, Clinical Operations, and Commercial teams to ensure regulatory requirements are met.
- Maintain regulatory databases and ensure the accuracy and completeness of regulatory documentation.
- Provide regulatory training and guidance to internal stakeholders.
- Conduct regulatory intelligence activities to stay ahead of evolving requirements.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience working effectively in a remote capacity, managing regulatory submissions and communications from a distance.
- In-depth knowledge of global pharmaceutical regulatory requirements and submission processes (e.g., ICH guidelines).
- Proven experience in preparing and submitting various types of regulatory filings.
- Excellent written and verbal communication skills, with a strong ability to articulate complex regulatory information clearly.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Proficiency in regulatory information management systems (RIMS) and document management systems.
- Ability to work independently, manage multiple priorities, and meet strict deadlines.
- Experience with a variety of therapeutic areas is a plus.
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7
Senior Risk Analyst, Regulatory Compliance
Posted 19 days ago
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Job Description
Our client, a rapidly growing international financial institution, is actively recruiting a Senior Risk Analyst with a focus on regulatory compliance. This is a fully remote position, offering a flexible work environment to manage complex risk portfolios. You will be responsible for identifying, assessing, and mitigating a broad spectrum of financial risks, ensuring adherence to stringent regulatory frameworks and internal policies. This includes developing and implementing robust risk management frameworks, conducting comprehensive risk assessments, and monitoring key risk indicators. You will analyze financial data, market trends, and operational processes to detect potential vulnerabilities and propose effective mitigation strategies. The role requires a deep understanding of banking regulations, anti-money laundering (AML) requirements, know-your-customer (KYC) procedures, and capital adequacy directives. You will prepare detailed risk reports for senior management and regulatory bodies, ensuring clarity and accuracy. Collaboration with legal, compliance, and business units across the organization will be essential to foster a strong risk-aware culture. The ability to interpret complex regulatory documents and translate them into actionable business processes is crucial. You will also be involved in developing and delivering risk management training programs to employees. This is an exceptional opportunity for a seasoned risk professional to make a significant contribution to a leading financial services organization, working remotely from any location, but supporting operations connected to Bungoma, Bungoma, KE .
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8
Lead Environmental Lawyer, Regulatory Compliance
Posted 19 days ago
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Job Description
Our client is seeking a highly experienced Lead Environmental Lawyer to champion their regulatory compliance and sustainability initiatives. This is a fully remote position, allowing you to provide expert legal counsel on environmental matters from anywhere. You will be responsible for interpreting and applying complex environmental laws and regulations, advising on compliance strategies, and managing environmental legal risks for the organization. This role involves close collaboration with internal teams, external counsel, and regulatory bodies. The ideal candidate possesses a deep understanding of national and international environmental legislation, strong analytical and problem-solving skills, and the ability to navigate intricate legal landscapes.
Key responsibilities include:
The successful candidate will hold a Bachelor of Laws (LLB) degree and a Post Graduate Diploma in Legal Practice, with at least 7 years of post-admission experience specializing in environmental law. Proven experience in regulatory compliance, environmental litigation, and transactional environmental work is essential. Strong research, writing, and advocacy skills are required. The ability to manage multiple priorities and work effectively in a remote, collaborative environment is crucial. This is an excellent opportunity to make a significant impact on environmental stewardship within a forward-thinking organization, supporting operations near Malindi, Kilifi, KE .
Key responsibilities include:
- Providing expert legal advice on all aspects of environmental law and regulations relevant to the company's operations.
- Ensuring the company's compliance with environmental permits, licenses, and reporting requirements.
- Developing and implementing environmental compliance policies and procedures.
- Reviewing and advising on environmental impact assessments (EIAs) and related documentation.
- Representing the company in legal proceedings, administrative hearings, and negotiations with regulatory agencies.
- Assisting in the management of environmental liabilities and remediation efforts.
- Staying abreast of evolving environmental legislation, case law, and policy changes.
- Conducting legal research and providing analysis on emerging environmental issues.
- Advising on sustainable business practices and corporate social responsibility initiatives.
- Collaborating with engineering, operations, and EHS (Environment, Health, and Safety) teams to mitigate environmental risks.
The successful candidate will hold a Bachelor of Laws (LLB) degree and a Post Graduate Diploma in Legal Practice, with at least 7 years of post-admission experience specializing in environmental law. Proven experience in regulatory compliance, environmental litigation, and transactional environmental work is essential. Strong research, writing, and advocacy skills are required. The ability to manage multiple priorities and work effectively in a remote, collaborative environment is crucial. This is an excellent opportunity to make a significant impact on environmental stewardship within a forward-thinking organization, supporting operations near Malindi, Kilifi, KE .
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