166 Regulatory Affairs jobs in Kenya

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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.