5 Senior Remote Pharmaceutical Regulatory Affairs Specialist jobs in whatjobs
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
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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.
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 13 days ago
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Job Description
Responsibilities:
- Prepare, review, and submit regulatory dossiers for pharmaceutical products to health authorities (e.g., NAFDAC, PPB, FDA, EMA).
- Manage and maintain product registrations, licenses, and variations.
- Interpret and communicate evolving national and international regulatory requirements to relevant teams.
- Advise project teams on regulatory strategies and compliance requirements throughout the product lifecycle.
- Assess the regulatory impact of product changes, manufacturing processes, and labeling updates.
- Oversee post-marketing surveillance activities, including adverse event reporting and pharmacovigilance.
- Conduct regulatory intelligence gathering and analysis to anticipate future trends and requirements.
- Liaise with regulatory agencies to address queries and facilitate the approval process.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant guidelines.
- Review marketing materials and promotional claims for regulatory compliance.
- Develop and implement regulatory strategies to support product development and commercialization.
- Maintain regulatory databases and documentation with utmost accuracy.
- Master's degree or Ph.D. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific field.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory requirements for drug products in key markets (e.g., Kenya, EU, US).
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
- Strong understanding of pharmaceutical development, manufacturing, and quality assurance.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication and negotiation skills.
- Proficiency in regulatory information management systems and relevant software.
- Ability to work independently and manage multiple projects effectively in a remote environment.
- Strong organizational skills and meticulous attention to detail.
- Demonstrated ability to build relationships with regulatory authorities.
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 5 days ago
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Job Description
Key Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and registration.
- Prepare, review, and submit regulatory dossiers to health authorities (e.g., FDA, EMA, national agencies).
- Interpret and advise on complex regulatory requirements, guidelines, and policies.
- Manage regulatory project timelines and ensure timely submission of all required documentation.
- Liaise with health authorities and respond to their queries and requests during the review process.
- Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations.
- Collaborate closely with R&D, clinical development, manufacturing, and commercial teams.
- Provide regulatory input for labeling, advertising, and promotional materials.
- Conduct regulatory intelligence activities and stay updated on industry best practices.
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree or PhD is a significant advantage.
- Minimum of 7-10 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets.
- In-depth knowledge of global regulatory requirements for pharmaceuticals.
- Excellent understanding of drug development processes, clinical trials, and manufacturing.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Proficiency in regulatory information management (RIM) systems and document management systems.
- Ability to manage multiple projects, prioritize tasks, and work effectively under pressure in a remote setting.
- Detail-oriented, highly organized, and committed to accuracy.
- A dedicated home office with a stable, high-speed internet connection is mandatory for this fully remote role, supporting our client's global operations that may involve regulatory activities impacting the Eldoret, Uasin Gishu, KE region and beyond.
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Responsibilities:
- Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Interpret and advise on regulatory requirements, guidelines, and changes impacting pharmaceutical products.
- Liaise effectively with regulatory agencies, acting as the primary point of contact for submissions and inquiries.
- Collaborate closely with cross-functional teams, including R&D, clinical affairs, quality assurance, manufacturing, and marketing, to ensure alignment with regulatory strategies.
- Provide regulatory input and guidance throughout the product development lifecycle, from early-stage research to post-market activities.
- Oversee and manage post-approval regulatory activities, including annual reports, supplements, and labeling updates.
- Conduct regulatory intelligence activities to stay informed about global regulatory trends and competitor strategies.
- Ensure compliance with all applicable national and international pharmaceutical regulations and guidelines.
- Contribute to the development and implementation of departmental SOPs and best practices.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 8 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission processes and requirements in major markets (e.g., FDA, EMA, PMDA).
- Proven experience in preparing and submitting complex regulatory dossiers.
- Strong understanding of drug development processes, clinical trials, and manufacturing controls.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly and concisely.
- Demonstrated ability to manage multiple projects simultaneously and meet strict deadlines in a remote environment.
- Proficiency in regulatory information management systems and documentation tools.
- Ability to work independently and as part of a global, virtual team.
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 3 days ago
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