504 Lead AI Ethics Governance Specialist 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

• 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.

• 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.

• Develop and execute comprehensive regulatory strategies for product development, registration, and lifecycle management.
• Interpret and apply global regulatory guidelines (e.g., FDA, EMA, ICH) to ensure compliance across all stages of drug development.
• Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
• Liaise directly with regulatory agencies, manage communications, and respond to agency queries.
• Provide regulatory guidance and support to R&D, clinical, manufacturing, and commercial teams.
• Assess regulatory risks and develop mitigation plans for product development and commercialization.
• Monitor regulatory changes and industry trends, advising the organization on potential impacts.
• Oversee post-approval regulatory activities, including supplements, variations, and annual reports.
• Manage regulatory submission timelines and ensure adherence to project milestones.
• Review and approve labeling, promotional materials, and advertising for regulatory compliance.
• Contribute to the development and implementation of departmental SOPs and best practices.
• Mentor and guide junior regulatory affairs professionals.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Ph.D. is a plus.
• A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of global pharmaceutical regulatory requirements and guidelines.
• Experience with diverse therapeutic areas and dosage forms.
• Strong understanding of drug development processes, from preclinical to post-marketing.
• Excellent written and verbal communication skills, with the ability to negotiate and influence.
• Exceptional analytical and problem-solving abilities.
• Demonstrated ability to work independently, manage multiple projects, and meet tight deadlines in a remote setting.
• Experience with regulatory information management systems is beneficial.
• Strong leadership and team collaboration skills.

• Develop and execute global regulatory strategies for pharmaceutical products.
• Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, MAA) to health authorities.
• Manage post-approval regulatory activities, including variations and lifecycle management.
• Liaise with health authorities to facilitate the regulatory review process.
• Advise R&D, clinical, and manufacturing teams on regulatory requirements and strategy.
• Assess the regulatory impact of product changes and deviations.
• Ensure compliance with relevant pharmaceutical regulations and guidelines (GMP, GCP, GVP).
• Monitor regulatory intelligence and advise on evolving global requirements.
• Maintain regulatory documentation and databases.
• Contribute to regulatory inspections and audits.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science. Master's degree or Pharm.D. is preferred.
• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH, etc.).
• Proven experience in preparing and submitting various regulatory filings.
• Strong understanding of pharmaceutical product development and lifecycle management.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills.
• Ability to manage multiple projects effectively and meet tight deadlines in a remote environment.
• Detail-oriented with a strong commitment to compliance and quality.

• 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.

• 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.