229 Regulatory Affairs Specialist jobs in Kenya
Regulatory Affairs Specialist
Nairobi, Nairobi
KES600000 - KES1200000 Y
Corevix
Posted today
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Job Description
Company Description
At COREVIX, we are committed to redefining the aesthetics industry across East Africa by enhancing access to the world's finest beauty and wellness innovations. Through a network of premium medical spas and a portfolio of high-quality consumables, we deliver cutting-edge treatments, advanced technology, and expert-driven solutions. Guided by excellence, innovation, and a customer-centric approach, we strive to inspire confidence, transform lives, and shape the future of aesthetics in the region.
Role Description
This is a full-time on-site role for a Regulatory Affairs Specialist located in Nairobi County, Kenya. The Regulatory Affairs Specialist will be responsible for preparing and submitting regulatory documents, ensuring compliance with regulatory requirements, managing regulatory submissions, and staying up-to-date with regulatory affairs. The Specialist will also liaise with different departments to ensure all regulatory documentation is accurate and meets relevant standards.
Qualifications
- Experience with Regulatory Documentation and Regulatory Submissions
- Knowledge of Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
- Strong attention to detail and excellent organizational skills
- Ability to work collaboratively and communicate effectively with cross-functional teams
- Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or Chemistry
- At least 2 years of experience in regulatory affairs or a related field
- Proficiency with regulatory software and data management systems
- Fluency in English and Swahili would be an advantage
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0
Senior Regulatory Affairs Specialist
20100 Nyeri Town
KES700000 Annually
WhatJobs
Posted today
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Job Description
Our client, a leading pharmaceutical research and development firm, is seeking a highly competent and detail-oriented Senior Regulatory Affairs Specialist. This position is entirely remote, allowing you to contribute to global drug development from your home office. You will be responsible for navigating the complex regulatory landscape, ensuring compliance with all applicable laws and guidelines for drug submissions and approvals.
As a Senior Regulatory Affairs Specialist, you will play a critical role in the strategic planning and execution of regulatory submissions for new drug applications (NDAs), investigational new drug applications (INDs), and variations. Your expertise in regulatory strategy, dossier preparation, and interaction with health authorities will be paramount. You will work closely with R&D, clinical, and manufacturing teams to ensure that all documentation meets the stringent requirements of regulatory agencies. The ideal candidate possesses a strong understanding of pharmaceutical regulations, excellent analytical and writing skills, and the ability to manage multiple complex projects simultaneously in a remote setting.
Key Responsibilities:
As a Senior Regulatory Affairs Specialist, you will play a critical role in the strategic planning and execution of regulatory submissions for new drug applications (NDAs), investigational new drug applications (INDs), and variations. Your expertise in regulatory strategy, dossier preparation, and interaction with health authorities will be paramount. You will work closely with R&D, clinical, and manufacturing teams to ensure that all documentation meets the stringent requirements of regulatory agencies. The ideal candidate possesses a strong understanding of pharmaceutical regulations, excellent analytical and writing skills, and the ability to manage multiple complex projects simultaneously in a remote setting.
Key Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, variations) to health authorities worldwide.
- Liaise with regulatory agencies to facilitate timely review and approval of submissions.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing.
- Interpret and apply relevant national and international regulations, guidelines, and standards.
- Monitor regulatory changes and assess their impact on company products and strategies.
- Manage post-approval regulatory commitments and lifecycle management activities.
- Conduct regulatory intelligence gathering and competitor analysis.
- Contribute to the development and maintenance of regulatory procedures and policies.
- Review promotional materials for regulatory compliance.
- Ensure all regulatory documentation is accurate, complete, and compliant.
- Lead regulatory interactions during inspections and audits.
- A Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. Advanced degree preferred.
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Excellent scientific understanding of drug development processes.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a keen eye for detail.
- Proficiency in regulatory information management systems and document management systems.
- Ability to manage multiple projects, prioritize tasks, and meet tight deadlines in a fast-paced, remote environment.
- Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.
- Eligibility to work remotely from Nyeri, Nyeri, KE or other locations in Kenya.
This advertiser has chosen not to accept applicants from your region.
1
Senior Regulatory Affairs Specialist
00200 Ngong
KES130000 Annually
WhatJobs
Posted 3 days ago
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Job Description
Our client is seeking a highly experienced Senior Regulatory Affairs Specialist to ensure compliance with pharmaceutical regulations. This is a fully remote position, enabling you to contribute to vital regulatory processes from anywhere in Kenya. The ideal candidate will possess in-depth knowledge of pharmaceutical regulatory frameworks, extensive experience in preparing and submitting regulatory dossiers, and a meticulous approach to documentation. You will be responsible for navigating complex regulatory landscapes, liaising with health authorities, and ensuring that all products meet the required legal and scientific standards for market approval and ongoing compliance. This role demands strong analytical skills, exceptional attention to detail, and the ability to communicate complex regulatory information effectively.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and implement regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit regulatory documentation (e.g., CTD modules, variations, renewals) to health authorities.
- Interpret and apply relevant national and international pharmaceutical regulations.
- Liaise effectively with regulatory agencies (e.g., Pharmacy and Poisons Board) to facilitate product approvals and address queries.
- Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
- Monitor regulatory changes and assess their impact on the company's products and operations.
- Conduct regulatory compliance assessments and ensure adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) where applicable.
- Manage post-approval regulatory activities, including variations, supplements, and annual reports.
- Review and approve labeling and promotional materials for regulatory compliance.
- Maintain regulatory databases and ensure accurate record-keeping.
- Contribute to the development of internal regulatory policies and procedures.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; advanced degree (Master's or PhD) is a plus.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of Kenyan pharmaceutical regulations and guidelines.
- Experience with dossier preparation (e.g., eCTD format) and submission processes.
- Proven ability to interact with regulatory authorities.
- Strong understanding of drug development, manufacturing, and quality assurance principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional attention to detail and organizational abilities.
- Strong written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Ability to work independently, manage priorities, and meet tight deadlines in a remote environment.
- Proficiency in regulatory information management systems is desirable.
This advertiser has chosen not to accept applicants from your region.
2
Senior Regulatory Affairs Specialist
50100 Kakamega, Western
KES190000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company, is seeking an experienced Senior Regulatory Affairs Specialist to join their fully remote legal and compliance team. This critical role will focus on ensuring that all products meet stringent regulatory requirements across diverse international markets. You will be responsible for preparing and submitting regulatory filings, managing regulatory agency communications, and staying abreast of evolving regulatory landscapes. A deep understanding of pharmaceutical regulations, including GMP, GCP, and GLP, is essential.
Key responsibilities include developing regulatory strategies for product approvals, evaluating the regulatory implications of product changes, and leading interactions with health authorities. You will also contribute to the development of regulatory policies and procedures, conduct regulatory intelligence gathering, and support product lifecycle management. Collaboration with R&D, quality assurance, and commercial teams will be integral to success. The ideal candidate will possess exceptional analytical skills, meticulous attention to detail, and the ability to navigate complex regulatory frameworks with confidence. Strong project management and organizational skills are vital to manage multiple submissions and deadlines effectively.
This is a fully remote position, offering the flexibility to work from any location within Kenya. We are looking for candidates with a Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology), along with a minimum of 6 years of direct experience in pharmaceutical regulatory affairs. Experience with specific therapeutic areas or global regulatory submissions (e.g., FDA, EMA) is highly advantageous. Excellent written and verbal communication skills are required for preparing clear and concise regulatory documentation and engaging with regulatory agencies. Join a leading organization that values scientific rigor and offers significant opportunities for professional growth and impact in the pharmaceutical industry.
Key responsibilities include developing regulatory strategies for product approvals, evaluating the regulatory implications of product changes, and leading interactions with health authorities. You will also contribute to the development of regulatory policies and procedures, conduct regulatory intelligence gathering, and support product lifecycle management. Collaboration with R&D, quality assurance, and commercial teams will be integral to success. The ideal candidate will possess exceptional analytical skills, meticulous attention to detail, and the ability to navigate complex regulatory frameworks with confidence. Strong project management and organizational skills are vital to manage multiple submissions and deadlines effectively.
This is a fully remote position, offering the flexibility to work from any location within Kenya. We are looking for candidates with a Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology), along with a minimum of 6 years of direct experience in pharmaceutical regulatory affairs. Experience with specific therapeutic areas or global regulatory submissions (e.g., FDA, EMA) is highly advantageous. Excellent written and verbal communication skills are required for preparing clear and concise regulatory documentation and engaging with regulatory agencies. Join a leading organization that values scientific rigor and offers significant opportunities for professional growth and impact in the pharmaceutical industry.
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist
60200 Meru , Eastern
KES170000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a global pharmaceutical company committed to improving health outcomes, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team on a fully remote basis. This role offers the chance to impact product development and market access from anywhere in Kenya.
The Senior Regulatory Affairs Specialist will be responsible for developing and executing regulatory strategies for product registration and lifecycle management. You will ensure compliance with all relevant regulatory requirements in target markets, prepare and submit regulatory documentation, and serve as a key liaison with health authorities. This position demands a deep understanding of pharmaceutical regulations and excellent communication skills.
Key Responsibilities:
Qualifications:
The Senior Regulatory Affairs Specialist will be responsible for developing and executing regulatory strategies for product registration and lifecycle management. You will ensure compliance with all relevant regulatory requirements in target markets, prepare and submit regulatory documentation, and serve as a key liaison with health authorities. This position demands a deep understanding of pharmaceutical regulations and excellent communication skills.
Key Responsibilities:
- Develop and implement regulatory strategies for new product registrations and post-approval changes.
- Prepare, review, and submit high-quality regulatory dossiers to health authorities in accordance with applicable guidelines (e.g., ICH, WHO).
- Serve as the primary point of contact for regulatory agencies, responding to queries and facilitating communication.
- Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
- Ensure compliance with all relevant pharmaceutical regulations, guidelines, and company policies.
- Collaborate closely with cross-functional teams, including R&D, quality assurance, manufacturing, and marketing, to ensure alignment on regulatory matters.
- Manage the regulatory review and approval process for labeling, promotional materials, and advertising.
- Provide regulatory guidance and training to internal stakeholders.
- Maintain regulatory documentation and databases.
- Participate in regulatory intelligence activities and competitor analysis.
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.
- Proven experience in preparing and submitting regulatory dossiers for various types of medicinal products.
- In-depth knowledge of global pharmaceutical regulations and guidelines.
- Excellent understanding of drug development processes and lifecycle management.
- Strong analytical and problem-solving skills.
- Exceptional written and verbal communication skills, with meticulous attention to detail.
- Ability to work independently, manage multiple priorities, and meet tight deadlines in a remote setting.
- Proficiency in regulatory information management systems is a plus.
- Must be legally authorized to work in Kenya.
This advertiser has chosen not to accept applicants from your region.
4
Principal Regulatory Affairs Specialist
30200 Tuwan
KES110000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and strategic Principal Regulatory Affairs Specialist to join their globally distributed team. This fully remote position, with a conceptual link to Eldoret, Uasin Gishu, KE , offers a unique opportunity to shape regulatory strategies for innovative pharmaceutical products. You will be responsible for overseeing and managing all aspects of regulatory submissions, ensuring compliance with global health authority requirements across various markets. This includes preparing and filing Investigational New Drug (IND) applications, New Drug Applications (NDA), and other relevant regulatory dossiers. You will conduct comprehensive regulatory intelligence gathering, analyze emerging trends, and provide expert guidance to cross-functional teams, including R&D, clinical, and manufacturing. The ideal candidate will possess a deep understanding of global pharmaceutical regulations, including those of the FDA, EMA, and other key health authorities. A proven track record of successful regulatory submissions and interactions with regulatory agencies is essential. Strong analytical, problem-solving, and communication skills are critical, along with the ability to manage complex projects in a fast-paced, remote environment. You will be expected to lead regulatory strategy development, identify potential regulatory risks, and propose mitigation plans. Experience in post-approval regulatory activities, including lifecycle management and variations, is also highly valued. This role requires meticulous attention to detail, exceptional organizational skills, and the ability to work independently with minimal supervision. You will play a key role in ensuring the timely approval and market access of our client's pipeline of life-changing medicines. This is an exciting opportunity to make a significant impact on global health by ensuring compliance and facilitating innovation.
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5
Pharmaceutical Regulatory Affairs Specialist
20117 Mwembe
KES380000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a highly skilled and meticulous Pharmaceutical Regulatory Affairs Specialist. This is a fully remote position, offering the flexibility to work from anywhere while contributing to critical regulatory submissions and strategies. You will be responsible for ensuring compliance with all relevant national and international pharmaceutical regulations. This includes preparing, compiling, and submitting regulatory dossiers for new drug applications, variations, and post-approval changes. The ideal candidate will possess a deep understanding of regulatory requirements across various markets, exceptional attention to detail, and strong scientific writing skills. You will liaise with regulatory authorities, manage submission timelines, and stay abreast of evolving regulatory landscapes. This role requires a proactive approach to identifying potential regulatory challenges and developing effective solutions. Collaboration with R&D, manufacturing, and quality assurance teams will be integral to your success. We are seeking an individual with a strong scientific background and a proven ability to navigate complex regulatory frameworks. If you are passionate about ensuring patient access to safe and effective medicines through expert regulatory guidance, this is an exceptional opportunity. This fully remote role supports operations relevant to the Naivasha, Nakuru, KE region.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for product registrations, variations, and renewals in accordance with global regulatory guidelines.
- Maintain a thorough understanding of current and emerging pharmaceutical regulations and guidelines in target markets.
- Liaise with national and international health authorities on regulatory submissions and inquiries.
- Assess the regulatory implications of product changes, manufacturing processes, and quality systems.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Ensure compliance with labeling requirements and review promotional materials for regulatory accuracy.
- Manage the lifecycle of regulatory approvals and maintain regulatory documentation.
- Conduct regulatory intelligence activities to identify new requirements and opportunities.
- Participate in regulatory audits and inspections as required.
- Develop and implement regulatory strategies to support product development and lifecycle management.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A higher degree or specialized certifications in Regulatory Affairs are highly desirable.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD, eCTD).
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Excellent scientific writing, analytical, and problem-solving skills.
- Strong attention to detail and accuracy.
- Effective communication and interpersonal skills, with the ability to collaborate with diverse teams.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work independently and manage multiple projects in a remote setting.
This advertiser has chosen not to accept applicants from your region.
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6
Pharmaceutical Regulatory Affairs Specialist
60701 Meru , Eastern
KES6000000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly motivated and experienced Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This role is essential for ensuring compliance with all national and international regulations governing pharmaceutical products. This is a fully remote position, allowing you to contribute your expertise from anywhere. You will be responsible for preparing and submitting regulatory filings, interacting with health authorities, and staying abreast of evolving regulatory landscapes. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and other regulatory submissions in accordance with relevant guidelines.
- Liaise with regulatory agencies (e.g., FDA, EMA, WHO) to facilitate the approval process and respond to queries.
- Monitor and interpret regulatory guidelines and advise project teams on their impact.
- Ensure that all company products comply with current regulatory requirements in target markets.
- Maintain regulatory databases and ensure the accuracy of product registration information.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing departments to gather necessary data for submissions.
- Develop and maintain regulatory strategies for product development and lifecycle management.
- Review and approve labeling, promotional materials, and advertising for regulatory compliance.
- Manage post-approval changes and ensure timely submissions of variations.
- Participate in regulatory inspections and audits.
- Stay informed about global regulatory trends and competitor activities.
- Provide training to internal staff on regulatory requirements and best practices.
- Assess the regulatory feasibility of new product concepts and development plans.
- Contribute to the continuous improvement of regulatory processes and systems.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting various types of regulatory dossiers (e.g., CTD format).
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines.
- Familiarity with regulatory submission platforms and e-filing processes.
- Excellent understanding of drug development processes, manufacturing, and quality control.
- Strong analytical and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Meticulous attention to detail and commitment to accuracy.
- Ability to work independently and manage multiple projects simultaneously in a remote environment.
- Strong interpersonal skills for effective collaboration with cross-functional teams and health authorities.
- Proficiency in using regulatory information management systems (RIMS) is a plus.
- Experience with biologics or specialized therapeutic areas is advantageous.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Specialist
70100 Gathiruini
KES140000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced Senior Regulatory Affairs Specialist to navigate and ensure compliance with complex legal and regulatory landscapes. This is a fully remote position, offering the flexibility to manage critical regulatory functions from any location. The successful candidate will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory documentation, and ensuring adherence to all applicable laws and guidelines. You will play a vital role in liaising with regulatory authorities and advising internal teams on regulatory requirements and changes. Key responsibilities include monitoring regulatory developments, assessing their impact on the company's operations, and developing strategies to ensure compliance. You will also be involved in the review of marketing materials, product labeling, and promotional activities to ensure they meet regulatory standards. This role demands a profound understanding of regulatory affairs principles, particularly within the company's industry. The ideal candidate will possess exceptional analytical, research, and communication skills, with a keen eye for detail and accuracy. Experience in managing complex regulatory submissions and a strong track record of successful interactions with regulatory bodies are essential. You will work collaboratively with cross-functional teams, including R&D, manufacturing, marketing, and legal, to ensure seamless integration of regulatory requirements throughout the product lifecycle. Our client values a proactive and strategic approach to regulatory compliance, and this role is instrumental in safeguarding the company's operations and reputation. The designated geographical context for this role, despite its remote nature, is **Mlolongo, Machakos, KE**, aligning with our client's operational reach and regulatory engagement in the region.
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8
Senior Pharmaceutical Regulatory Affairs Specialist
80100 Shella
KES320000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a progressive pharmaceutical company, is seeking an accomplished Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This position, with a focus on operations in **Malindi, Kilifi, KE**, will be responsible for navigating the complex landscape of pharmaceutical regulations, ensuring compliance with national and international standards for drug development, registration, and lifecycle management. You will play a critical role in preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic guidance on regulatory requirements.
Key responsibilities include monitoring and interpreting evolving regulatory guidelines, assessing the regulatory impact of proposed changes to products or processes, and developing regulatory strategies for product approvals and post-approval variations. You will work closely with R&D, manufacturing, and marketing teams to ensure regulatory compliance throughout product development and commercialization. This role demands meticulous attention to detail, a deep understanding of regulatory submission processes (e.g., CTD format), and strong analytical skills. You will be expected to manage multiple projects simultaneously, ensuring timely submissions and responses to regulatory agencies. Experience with specific therapeutic areas or product types (e.g., biologics, generics) is advantageous. The ability to effectively communicate complex regulatory information to diverse stakeholders in a remote setting is essential.
Qualifications:
Key responsibilities include monitoring and interpreting evolving regulatory guidelines, assessing the regulatory impact of proposed changes to products or processes, and developing regulatory strategies for product approvals and post-approval variations. You will work closely with R&D, manufacturing, and marketing teams to ensure regulatory compliance throughout product development and commercialization. This role demands meticulous attention to detail, a deep understanding of regulatory submission processes (e.g., CTD format), and strong analytical skills. You will be expected to manage multiple projects simultaneously, ensuring timely submissions and responses to regulatory agencies. Experience with specific therapeutic areas or product types (e.g., biologics, generics) is advantageous. The ability to effectively communicate complex regulatory information to diverse stakeholders in a remote setting is essential.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience in preparing and submitting regulatory dossiers to health authorities (e.g., KEBS, FDA, EMA).
- In-depth knowledge of pharmaceutical regulations, guidelines, and compliance requirements.
- Experience with post-approval activities, variations, and lifecycle management.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
- Strong analytical, problem-solving, and project management skills.
- Ability to work independently and manage time effectively in a remote work environment.
- Familiarity with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is a plus.
- Proficiency in relevant regulatory databases and software.
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9