Regulatory Affairs Manager

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 15).

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

Bachelors / Masters degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent.

812 years of regulatory affairs experience (pharma/biotech/nutraceuticals), with at least 35 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.