What Jobs are available for Regulatory Affairs Specialist in Kenya?
Showing 752 Regulatory Affairs Specialist jobs in Kenya
Regulatory Affairs Specialist
Posted 1 day ago
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Job Description
Our client is a respected entity within the pharmaceutical sector and is currently seeking a dedicated Regulatory Affairs Specialist to join their team. This position is based in Garissa, Garissa, KE and requires the candidate to be present on-site. The ideal candidate will possess a thorough understanding of pharmaceutical regulations and a proven ability to navigate complex compliance landscapes. You will be instrumental in ensuring that all company products meet the stringent requirements set forth by regulatory bodies.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for new product registrations and variations.
- Monitor and interpret evolving regulatory requirements in relevant markets.
- Liaise with regulatory agencies to facilitate product approvals and address inquiries.
- Develop and maintain regulatory strategies for product lifecycle management.
- Ensure compliance with local and international pharmaceutical regulations, including Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
- Collaborate with R&D, Quality Assurance, and Marketing departments to ensure regulatory requirements are integrated into product development and commercialization processes.
- Provide regulatory guidance and support to cross-functional teams.
- Maintain accurate and up-to-date regulatory documentation and databases.
- Conduct regulatory assessments for new product development projects and line extensions.
- Manage post-approval regulatory activities, including annual reports and labeling updates.
- Participate in regulatory inspections and audits.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is a plus.
- Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
- Solid understanding of pharmaceutical regulatory frameworks in key markets (e.g., KEBS, EMA, FDA).
- Experience in preparing and submitting Common Technical Document (CTD) modules.
- Excellent knowledge of drug development processes and product lifecycle management.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
- Proficiency in regulatory information management systems.
- Ability to work independently and collaboratively in a team environment.
- High level of accuracy and meticulous attention to detail.
- Adaptability to changing regulatory landscapes and business priorities.
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Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 1 day ago
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Job Description
Our client is a rapidly growing pharmaceutical company seeking a highly competent and detail-oriented Senior Regulatory Affairs Specialist to join their international team. This is a fully remote position, offering an exceptional opportunity to contribute to the global drug development and approval process from your home office. You will be responsible for developing and executing regulatory strategies for product registration and lifecycle management in various target markets. This includes preparing and submitting regulatory dossiers (e.g., CTD, IND, NDA), liaising with health authorities, and ensuring compliance with global regulatory requirements and guidelines. Your expertise will be crucial in navigating complex regulatory landscapes and facilitating the timely market access of our innovative pharmaceutical products. The ideal candidate will possess a strong understanding of pharmaceutical product development, manufacturing, and quality assurance processes.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and registration.
- Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Serve as the primary point of contact for regulatory agencies, managing communications and responses.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Interpret and apply relevant regulatory guidelines and legislation.
- Manage the regulatory aspects of product lifecycle management, including post-approval changes and renewals.
- Conduct regulatory intelligence activities to stay abreast of evolving requirements and competitor activities.
- Review labeling, promotional materials, and advertising for regulatory compliance.
- Contribute to the development of regulatory policies and procedures.
- Ensure adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) where applicable.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- A minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
- Proven experience in preparing and submitting successful regulatory dossiers to major health authorities (e.g., FDA, EMA, PMDA).
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines (e.g., ICH).
- Strong understanding of drug development processes, clinical trials, and pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with a strong ability to write clear and concise regulatory documents.
- Proficiency in regulatory information management systems and common office software.
- Ability to work independently, manage multiple projects simultaneously, and meet demanding deadlines in a remote setting.
- Experience with biosimilars or biologics is a plus.
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1
Senior Regulatory Affairs Specialist, Biologics
Posted 1 day ago
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Job Description
Our client is seeking an accomplished Senior Regulatory Affairs Specialist with a deep understanding of biologics to join their globally distributed team. This is a 100% remote position, providing a unique opportunity to contribute to groundbreaking pharmaceutical development from your home office. You will be responsible for developing and executing regulatory strategies for the submission of new drug applications (NDAs) and biologics license applications (BLAs) to major health authorities, including the FDA, EMA, and other international regulatory bodies. Your role will involve preparing and reviewing regulatory submission documents, ensuring compliance with all applicable regulations and guidelines. You will actively engage with regulatory agencies, manage post-approval regulatory activities, and provide expert guidance on regulatory requirements throughout the product lifecycle. This position requires a thorough understanding of CMC (Chemistry, Manufacturing, and Controls) aspects of biologics, as well as clinical and non-clinical data requirements. You will collaborate closely with cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing, to ensure alignment and successful execution of regulatory plans. The ideal candidate will possess excellent analytical and problem-solving skills, with a proven ability to navigate complex regulatory landscapes. This role offers a challenging and rewarding environment for a dedicated regulatory affairs professional looking to make a significant impact in the pharmaceutical industry. The position is advertised for **Meru, Meru, KE**, but operates on a fully remote basis.
Key Responsibilities:
Required Qualifications:
Key Responsibilities:
- Develop and implement regulatory strategies for biologics products.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, BLAs, NDAs) to global health authorities.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant regulations.
- Liaise with regulatory agencies, respond to inquiries, and manage meetings.
- Oversee post-approval regulatory activities, including variations and annual reports.
- Provide regulatory guidance to project teams throughout the drug development process.
- Assess regulatory impact of changes in manufacturing processes or product formulations.
- Monitor changes in the global regulatory landscape and advise the company accordingly.
- Contribute to the development of regulatory intelligence and strategic planning.
- Manage external regulatory consultants and vendors as needed.
Required Qualifications:
- Master's degree or Ph.D. in a relevant scientific discipline (e.g., Pharmacy, Biology, Chemistry).
- Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a strong focus on biologics.
- Demonstrated success in preparing and submitting BLAs and NDAs.
- Comprehensive knowledge of FDA, EMA, and ICH guidelines.
- Experience with CMC documentation for biologics.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to manage multiple projects simultaneously and work effectively in a remote, cross-functional team environment.
- Strong negotiation and problem-solving skills.
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2
Lead Pharmaceutical Regulatory Affairs Specialist
Posted 1 day ago
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Job Description
Our client is seeking a highly experienced and strategic Lead Pharmaceutical Regulatory Affairs Specialist to join their fully remote global team. This pivotal role will oversee the regulatory strategy and execution for pharmaceutical products, ensuring compliance with international health authority regulations and guidelines. You will be responsible for preparing, submitting, and maintaining regulatory dossiers for drug approvals in various markets, managing post-approval changes, and providing expert guidance on regulatory requirements throughout the product lifecycle.
The ideal candidate possesses a deep understanding of pharmaceutical development, manufacturing, and quality systems, combined with extensive experience in navigating complex regulatory landscapes. You will lead a team of regulatory professionals, fostering collaboration and driving best practices in regulatory affairs. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to anticipate and address regulatory challenges proactively. Your role will involve close interaction with internal stakeholders (R&D, clinical, manufacturing, quality) and external regulatory agencies, all managed within a remote-first operational framework.
Key Responsibilities:
Qualifications:
This is a critical leadership role within a forward-thinking pharmaceutical company, offering the chance to shape regulatory strategies and contribute to bringing life-saving medicines to patients worldwide, all from a remote work setting.
The ideal candidate possesses a deep understanding of pharmaceutical development, manufacturing, and quality systems, combined with extensive experience in navigating complex regulatory landscapes. You will lead a team of regulatory professionals, fostering collaboration and driving best practices in regulatory affairs. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to anticipate and address regulatory challenges proactively. Your role will involve close interaction with internal stakeholders (R&D, clinical, manufacturing, quality) and external regulatory agencies, all managed within a remote-first operational framework.
Key Responsibilities:
- Develop and implement comprehensive global regulatory strategies for new and existing pharmaceutical products.
- Lead the preparation and submission of Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other marketing authorizations.
- Manage and maintain all regulatory filings, amendments, and renewals.
- Interpret and communicate complex regulatory requirements and guidelines to internal teams.
- Conduct regulatory intelligence activities to stay informed of evolving regulations and agency expectations.
- Oversee the regulatory review of labeling, promotional materials, and advertising.
- Liaise directly with health authorities (e.g., FDA, EMA, national agencies) on behalf of the company.
- Manage and mentor a team of regulatory affairs professionals, fostering their development and ensuring high performance.
- Contribute to the development and implementation of regulatory compliance programs.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree (Master's, Pharm.D., Ph.D.) strongly preferred.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global regulatory requirements (ICH, FDA, EMA, etc.).
- Experience managing and leading regulatory affairs teams.
- Excellent written and verbal communication skills, with strong negotiation abilities.
- Exceptional analytical and problem-solving skills, with meticulous attention to detail.
- Demonstrated ability to work effectively in a fully remote, collaborative environment, managing multiple projects and deadlines.
- Proficiency with regulatory information management systems is a plus.
This is a critical leadership role within a forward-thinking pharmaceutical company, offering the chance to shape regulatory strategies and contribute to bringing life-saving medicines to patients worldwide, all from a remote work setting.
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3
Senior Regulatory Affairs Specialist (Remote)
Posted 1 day ago
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Job Description
Our client is seeking an experienced Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This vital role ensures that products meet all necessary legal and regulatory requirements for market entry and compliance across various jurisdictions. You will be responsible for developing regulatory strategies, preparing submission dossiers, and maintaining communication with regulatory agencies worldwide. The ideal candidate possesses a strong understanding of regulatory frameworks, compliance procedures, and the specific requirements relevant to the company's industry, such as pharmaceuticals, medical devices, or consumer goods. As this is a remote-first position, exceptional organizational skills, meticulous attention to detail, and outstanding communication abilities are essential for successful collaboration with internal teams and external partners. Your responsibilities will include monitoring regulatory changes, advising product development teams on compliance, managing regulatory documentation, and supporting product registrations and approvals. We are looking for a proactive individual with strong analytical and problem-solving skills, capable of independently managing complex regulatory challenges. This is an excellent opportunity to leverage your expertise in regulatory affairs within a flexible, remote work environment, contributing directly to the company's global market access and success. Join us to navigate the complex regulatory landscape and facilitate the launch of innovative products.
Key Responsibilities:
Key Responsibilities:
- Develop and execute global regulatory strategies for product approvals and registrations.
- Prepare, review, and submit regulatory dossiers to health authorities (e.g., FDA, EMA, local agencies).
- Monitor and interpret evolving regulatory guidelines and standards.
- Advise R&D, marketing, and other departments on regulatory requirements and compliance.
- Manage post-market surveillance activities and regulatory reporting.
- Liaise with regulatory authorities and respond to inquiries.
- Ensure all product labeling and promotional materials are compliant.
- Maintain regulatory documentation and databases.
- Support regulatory audits and inspections.
- Contribute to risk assessment and mitigation strategies related to regulatory compliance.
- Bachelor's degree in a scientific, technical, or legal field. A Master's degree is a plus.
- Minimum of 6 years of experience in regulatory affairs within a relevant industry (e.g., pharmaceuticals, medical devices, biotech, food & beverage).
- Proven experience in preparing and submitting regulatory filings.
- In-depth knowledge of global regulatory submission processes and requirements.
- Familiarity with GxP (Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices) is often required.
- Excellent written and verbal communication skills.
- Strong analytical, problem-solving, and project management abilities.
- Ability to work independently and manage priorities effectively in a remote setting.
- Detail-oriented with a high degree of accuracy.
- Experience with specific regulatory bodies relevant to the company's markets is advantageous.
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4
Senior Regulatory Affairs Specialist - Pharmaceuticals - Remote
Posted 1 day 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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