Job Profile
The Regulatory Affairs Manager (RAM) for Africa, MENA, and LATAM will lead regulatory strategy, submissions, approvals, and life-cycle management of pharmaceutical, biotech, and nutraceutical products across these diverse regions. The role requires a strong understanding of local health authority requirements, WHO guidance, and international regulations (ICH, EMA, FDA), ensuring that products are registered, maintained, and compliant with country-specific laws while enabling timely market access.
This role demands strategic thinking, hands-on dossier management, strong liaison with regulatory bodies, and close coordination with global cross-functional teams.
Key Responsibilities
1. Regulatory Strategy & Intelligence
- Develop and execute region-specific regulatory strategies aligned with corporate goals and global standards.
- Conduct regulatory intelligence for Africa, MENA, and LATAM to anticipate changes in laws, guidelines, and market access requirements.
- Provide leadership and input into business development/licensing activities, assessing feasibility of new product registrations in target markets.
- Maintain a regulatory risk register for assigned countries, with mitigation strategies.
2. Dossier Preparation, Submission & Approvals
- Lead preparation, compilation, and review of regulatory dossiers in CTD/eCTD and local formats (Module 1–5).
- Coordinate with CMC, QA, Clinical, PV, and Supply Chain teams to ensure technical accuracy of dossiers.
- Manage submissions for new product registrations, renewals, variations, and post-approval changes.
- Maintain master tracking systems for submissions, approvals, renewals, and pending queries.
- Ensure high-quality translations of dossiers, product information, and labeling in Spanish, Portuguese, French, or Arabic where required.
3. Regulatory Compliance & Governance
- Ensure compliance with country-specific regulations across:
- Africa: SAHPRA (South Africa), PPB (Kenya), NAFDAC (Nigeria), TMDA (Tanzania), etc.
- MENA: SFDA (Saudi Arabia), MOHAP (UAE), CAPA (Egypt), JFDA (Jordan), etc.
- LATAM: ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru), etc.
- Oversee submissions for GMP/GDP certification, site registrations, and quality compliance.
- Ensure labeling, packaging, and promotional material compliance per regional laws.
- Manage responses to regulatory inspections, audits, and deficiency letters.
- Coordinate with WHO PQ (Prequalification) and regional harmonization initiatives (e.g., ZaZiBoNa in Africa).
4. Product Life-Cycle Management (LCM)
- Manage variations, renewals, and amendments to maintain up-to-date licenses.
- Coordinate post-marketing commitments (safety updates, labeling changes, PSUR/DSUR submissions).
- Ensure timely implementation of global safety labeling updates into regional product labels.
- Handle regulatory impact assessments for manufacturing changes, formulation updates, and pack-size introductions.
5. Stakeholder Engagement & Liaison
- Act as regulatory interface with health authorities, local affiliates, and distributors in assigned regions.
- Build strong working relationships with local RA consultants and regulatory bodies to accelerate approvals.
- Represent the company in regulatory authority meetings, inspections, and conferences.
- Partner with business development, PV, and quality teams to align regulatory strategy with patient safety and commercial goals.
6. Cross-Functional Collaboration
- Work with Pharmacovigilance teams to ensure regulatory submission of RMPs, PSURs, and adverse event-related labeling changes.
- Partner with Quality Assurance to ensure regulatory compliance of manufacturing and distribution sites.
- Collaborate with Supply Chain for timely product launches, customs clearances, and export documentation.
- Support Clinical Affairs for clinical trial applications (CTA) and approvals in LATAM/MENA regions.
7. Training, Documentation & Systems
- Develop and update SOPs, Work Instructions, and Regulatory Guidelines for Africa, MENA & LATAM submissions.
- Train internal teams and external partners on regulatory requirements and changes.
- Maintain regulatory information management systems (RIMS) for tracking submissions and renewals.
- Provide periodic regulatory reports to senior management on submission timelines, approvals, and risks.
Qualifications & Experience
- Bachelor’s / Master’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent.
- 8–12 years of regulatory affairs experience (pharma/biotech/nutraceuticals), with at least 3–5 years exposure to Africa, MENA, or LATAM.
- Hands-on experience with dossier preparation (CTD/eCTD), submissions, renewals, and LCM.
- Proven track record of successful product registrations in two or more of the focus regions.
- Strong knowledge of ICH guidelines, WHO PQ, and country-specific regulatory frameworks.
Skills & Competencies
- Regulatory Expertise: In-depth knowledge of registration requirements in diverse countries.
- Project Management: Ability to manage multi-country submissions and prioritize workload.
- Communication Skills: Excellent oral and written communication across cultures and time zones.
- Languages: Fluency in English mandatory; Spanish/Portuguese/French/Arabic highly desirable.
- Technical Tools: Familiarity with eCTD tools, RIMS, regulatory databases, MS Office.
- Problem-Solving: Strong analytical and decision-making skills for handling regulatory hurdles.
Key Attributes
- Patient-Centric & Ethical: Focus on ensuring compliance and patient access.
- Detail-Oriented: Precision in preparing, reviewing, and submitting documents.
- Adaptable & Culturally Aware: Ability to work effectively in diverse regulatory and cultural landscapes.
- Collaborative: Strong interpersonal skills to manage internal and external stakeholders.
- Strategic & Proactive: Anticipates regulatory changes and builds agile strategies.
Performance Indicators (KPIs)
- Timeliness of submissions, approvals, and renewals.
- Successful registration of new products in target markets.
- Compliance metrics (zero critical observations in audits/inspections).
- Accuracy and quality of regulatory dossiers.
- Effective collaboration with internal teams and regulatory authorities.
