8 Regulatory Affairs Specialists jobs in Nairobi

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 (e.g., CTD, IND, NDA, ANDA) to health authorities worldwide.
• Interpret and advise on regulatory requirements and guidelines for drug development, manufacturing, and marketing.
• Develop regulatory strategies to support product development and commercialization plans.
• Liaise with regulatory agencies (e.g., FDA, EMA, local authorities) on submissions, inquiries, and meetings.
• Manage post-approval regulatory activities, including variations, annual reports, and renewals.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
• Review promotional materials and labeling for regulatory compliance.
• Collaborate with R&D, Clinical, Quality Assurance, and Commercial teams to ensure regulatory requirements are met throughout the product lifecycle.
• Monitor regulatory intelligence and update company policies and procedures accordingly.
• Provide training to internal teams on regulatory requirements and best practices.
• Assess the regulatory impact of proposed product changes or new developments.
• Maintain accurate and organized regulatory records and databases.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• A minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global pharmaceutical regulations (e.g., ICH guidelines, US FDA, EMA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent understanding of drug development processes and product lifecycle management.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Exceptional written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
• Ability to work independently, manage priorities effectively, and meet strict deadlines in a remote setting.
• Strong interpersonal skills and the ability to collaborate effectively with diverse teams.
• Experience with regulatory information management systems is a plus.
• Pharmaceutical industry experience is mandatory.

• Develop, implement, and maintain comprehensive compliance programs and policies.
• Monitor regulatory changes and assess their impact on the company's operations.
• Conduct regular compliance risk assessments and implement mitigation strategies.
• Advise business units on compliance matters related to financial regulations, data privacy, anti-money laundering (AML), and know-your-customer (KYC) requirements.
• Manage internal and external audits and respond to regulatory inquiries.
• Develop and deliver compliance training to employees at all levels.
• Investigate compliance breaches and recommend corrective actions.
• Stay current with legal and regulatory developments affecting the financial services industry.
• Liaise with regulatory authorities and government agencies.
• Promote a strong culture of ethics and compliance throughout the organization.

• Law degree (LLB) from a recognized university and admission to the Kenyan Bar with a valid practicing certificate.
• Minimum of 8 years of experience in legal and compliance roles, preferably within the financial services industry.
• In-depth knowledge of Kenyan financial regulations, AML/KYC laws, data protection laws, and corporate governance.
• Proven experience in developing and implementing compliance programs and conducting risk assessments.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Strong written and verbal communication skills, with the ability to explain complex regulatory requirements clearly.
• Demonstrated ability to manage multiple projects and priorities in a remote environment.
• High level of integrity, professionalism, and ethical conduct.
• Experience in advising on international regulatory frameworks is a plus.

• Develop, implement, and manage comprehensive compliance programs and policies.
• Monitor changes in relevant laws and regulations and assess their impact on the business.
• Advise senior management and business units on regulatory requirements and compliance strategies.
• Conduct internal investigations and audits to ensure adherence to policies and regulations.
• Manage relationships with regulatory bodies and external auditors.
• Oversee the company's anti-money laundering (AML) and know your customer (KYC) initiatives.
• Provide legal guidance on data privacy regulations (e.g., GDPR, Kenyan Data Protection Act).
• Develop and deliver compliance training programs for employees.
• Review and advise on marketing materials and product offerings for regulatory compliance.
• Manage regulatory filings and reporting obligations.
• Represent the company in interactions with regulatory agencies.

• Develop and implement global regulatory strategies for pharmaceutical products.
• Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, CTAs).
• Liaise with regulatory health authorities worldwide.
• Ensure compliance with all applicable pharmaceutical regulations and guidelines.
• Advise project teams on regulatory requirements throughout the product lifecycle.
• Monitor and interpret changes in global pharmaceutical regulations.
• Conduct regulatory intelligence gathering and analysis.
• Manage post-approval regulatory activities, including lifecycle management.
• Review and approve labeling and promotional materials for regulatory compliance.
• Contribute to the development of SOPs and internal regulatory policies.

• Master's degree or Pharm.D. in Pharmacy, Life Sciences, or a related field.
• Extensive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global pharmaceutical regulatory requirements and submission processes.
• Proven track record of successful regulatory submissions.
• Strong analytical, strategic thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently, manage projects effectively, and meet strict deadlines in a remote setting.
• Experience with regulatory information management systems is a plus.
• Familiarity with different therapeutic areas is advantageous.

• Develop and implement global regulatory strategies for product development and lifecycle management.
• Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
• Serve as the primary regulatory contact for assigned projects and products.
• Respond to questions and requests from regulatory agencies.
• Monitor and interpret evolving regulatory guidelines and legislation impacting the pharmaceutical industry.
• Provide regulatory guidance and support to R&D, Quality, and Commercial teams.
• Assess the regulatory impact of proposed changes to product manufacturing, labeling, and marketing.
• Ensure compliance with all applicable GMP, GCP, and GLP regulations.
• Manage post-approval regulatory activities, including supplements and variations.
• Maintain regulatory documentation and databases.
• Contribute to the continuous improvement of regulatory processes and systems.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline; Master's degree or Pharm.D. is a plus.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Comprehensive knowledge of global regulatory submission requirements and guidelines (e.g., FDA, EMA, ICH).
• Proven experience in preparing and submitting major regulatory filings.
• Excellent understanding of drug development processes and pharmaceutical manufacturing.
• Strong analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple priorities in a remote setting.
• Detail-oriented with strong organizational skills.