192 Senior Regulatory Affairs Specialist jobs in Kenya
Regulatory Affairs Specialist
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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Regulatory Affairs Specialist
Posted 3 days 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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1
Principal Regulatory Affairs Specialist
Posted 20 days ago
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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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2
Senior Regulatory Affairs Specialist
Posted 20 days ago
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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.
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3
Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 20 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to improving global health outcomes, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their remote team. This critical role involves ensuring compliance with all relevant national and international regulations for our client's pharmaceutical products.
The successful candidate will be responsible for managing the regulatory submission process, maintaining product registrations, and providing expert guidance on regulatory requirements. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills to liaise with health authorities and internal departments.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a dedicated regulatory affairs professional to advance their career with a leading pharmaceutical innovator, enjoying the flexibility of a fully remote role. Contribute to bringing life-changing medicines to patients worldwide.
Although the role is remote, the company has a significant presence and focus in the region of Naivasha, Nakuru, KE .
The successful candidate will be responsible for managing the regulatory submission process, maintaining product registrations, and providing expert guidance on regulatory requirements. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills to liaise with health authorities and internal departments.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
- Manage and maintain product registrations and licenses, ensuring timely renewals and compliance with post-approval commitments.
- Interpret and advise on complex regulatory requirements, guidelines, and changes affecting pharmaceutical products.
- Develop regulatory strategies for new product development and lifecycle management.
- Act as the primary point of contact for regulatory health authorities, addressing inquiries and facilitating communication.
- Review and approve labeling, promotional materials, and advertising for compliance with regulations.
- Conduct regulatory intelligence activities to monitor evolving legislation and provide proactive guidance.
- Collaborate with R&D, Quality Assurance, Clinical Affairs, and Commercial departments to ensure regulatory compliance throughout the product lifecycle.
- Identify and assess regulatory risks and develop mitigation strategies.
- Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs).
- Mentor junior regulatory affairs personnel.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. Advanced degree (Master's or PharmD) is preferred.
- Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals across multiple global markets.
- In-depth knowledge of global regulatory guidelines (e.g., ICH, FDA, EMA, WHO).
- Experience with electronic submission portals and regulatory information management systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management abilities and the capacity to manage multiple complex projects simultaneously.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly and concisely.
- Ability to work independently and collaboratively in a fast-paced, remote environment.
- High ethical standards and commitment to compliance.
This is an exceptional opportunity for a dedicated regulatory affairs professional to advance their career with a leading pharmaceutical innovator, enjoying the flexibility of a fully remote role. Contribute to bringing life-changing medicines to patients worldwide.
Although the role is remote, the company has a significant presence and focus in the region of Naivasha, Nakuru, KE .
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4
Senior Regulatory Affairs Specialist, Biologics
Posted 4 days 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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5
Pharmaceutical Regulatory Affairs Specialist
Posted 20 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.
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6
Lead Pharmaceutical Regulatory Affairs Specialist
Posted 17 days 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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7
Senior Regulatory Affairs Specialist (Remote)
Posted 5 days ago
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Job Description
Our client is seeking a seasoned Senior Regulatory Affairs Specialist to join their entirely remote legal department. In this crucial role, you will be responsible for ensuring compliance with all relevant local and international regulations for our products and services. You will navigate the complex landscape of regulatory requirements, developing and implementing strategies to achieve and maintain compliance. This position demands a thorough understanding of regulatory frameworks applicable to our industry, including product registration, labeling, advertising, and post-market surveillance. You will prepare and submit regulatory dossiers, respond to inquiries from regulatory authorities, and stay abreast of changes in regulations that may impact the business. Collaboration with internal teams, including R&D, Quality Assurance, and Marketing, will be essential to ensure regulatory considerations are integrated throughout the product lifecycle. The ideal candidate will possess exceptional attention to detail, strong analytical skills, and the ability to interpret and apply complex regulatory guidelines. You should be an excellent communicator, capable of explaining regulatory requirements and strategies to diverse audiences. Experience in managing regulatory submissions and interactions with health authorities or other relevant agencies is paramount. This role offers a fantastic opportunity to work remotely, contributing to critical compliance efforts from your home office. You will be instrumental in safeguarding the company's reputation and market access by ensuring adherence to the highest regulatory standards. The ability to work independently, manage deadlines effectively, and adapt to a rapidly evolving regulatory environment is key. This position requires a proactive approach to identifying potential regulatory challenges and developing innovative solutions. You will be a trusted advisor on all matters related to regulatory affairs, contributing to the strategic direction of the company.
Responsibilities:
Responsibilities:
- Develop and implement regulatory strategies for product approvals and compliance.
- Prepare and submit regulatory applications, dossiers, and documentation.
- Liaise with regulatory authorities and respond to inquiries.
- Monitor and interpret regulatory changes and assess their impact on the business.
- Provide regulatory guidance and support to cross-functional teams.
- Ensure compliance with labeling, advertising, and promotional regulations.
- Manage post-market surveillance activities and regulatory reporting.
- Conduct regulatory training for internal stakeholders.
- Maintain regulatory databases and documentation.
- Participate in regulatory audits and inspections.
- Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
- Minimum of 5-7 years of experience in regulatory affairs, preferably within a regulated industry.
- Thorough understanding of relevant regulatory landscapes and guidelines.
- Proven experience in preparing and submitting regulatory dossiers.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and manage multiple projects effectively in a remote setting.
- Detail-oriented with a high level of accuracy.
- Proficiency in regulatory information management systems is a plus.
- Experience with international regulatory submissions is desirable.
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8
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
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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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