GxP Regulatory Intelligence Associate

1. Regulatory Intelligence Collection

•             Proactively monitor, identify, and collect regulatory intelligence from competent authorities, government bodies, regulatory agencies, and official publications across 47 countries in the Middle Africa region.

•             Track and capture a broad range of intelligence types, including but not limited to:

–            Acts and Regulations (primary legislation)

–            Guidelines and Guidance Documents

–            Regulatory Forms (new or revised)

–            Notifications and Circulars

–            Official Memos and Communiqués

–            Draft documents and Final published documents

–            Announcements and Policy Updates

•             Engage with local regulatory agents, distributors, and industry associations to supplement intelligence gathered through formal channels.

2. Regulatory Intelligence Impact Assessment

•             Critically evaluate collected regulatory intelligence to determine:

–            Relevance to Company operations and product portfolio in the Middle Africa region

–            Impact level on GxP functional areas

–            Urgency and implementation timelines

–            Compliance obligations arising from new or amended regulations

•             Perform gap analyses between current Company practices and emerging regulatory requirements.

•             Prioritize intelligence based on business risk, compliance deadlines, and potential operational impact.

•             Provide preliminary interpretation and context for complex regulatory documents.

3. Regulatory Intelligence Delivery & Communication

•             Ensure timely and structured dissemination of regulatory intelligence to the following GxP cross-functional teams:

–            Regulatory Affairs (RA)

–            Pharmacovigilance (PV)

–            Marketing and Market Access (MA)

–            Medical Affairs (as applicable)

–            Supply Chain and Logistics

–            Quality Assurance (QA)

•             Develop and distribute:

–            Regulatory Intelligence Reports

–            Regulatory Alerts for urgent or time-sensitive updates

–            Impact Assessment Reports

•             Tailor communication formats and content to the specific needs and priorities of each functional team.

•             Present regulatory intelligence findings during cross-functional meetings, governance forums, and leadership reviews as required.

4. Regulatory Intelligence Repository Management

•             Establish, maintain, and continuously update a centralized and accessible list of applicable regulatory intelligence database/repository covering all 47 countries in scope.

•             Ensure proper version control, archiving, and retrieval of regulatory documents in compliance with Company document management standards.

•             Ensure accurate tracking of key submission deadlines, consultation periods, and implementation dates.

•             Implement and improve systems, tools, and processes for efficient intelligence management.

5. Stakeholder Engagement & Collaboration

•             Build and maintain relationships with local regulatory agents, industry bodies, and regulatory authority contacts across the countries in scope.

•             Collaborate with Global Regulatory Intelligence teams to align actions in line with the local requirements.

•             Participate in industry working groups, regulatory forums, and associations relevant to the Middle Africa region.

6. Compliance & Quality

•             Ensure all regulatory intelligence activities are conducted in accordance with applicable GxP standards, Company SOPs, and internal policies.

•             Support regulatory compliance initiatives by providing timely intelligence that enables proactive responses to regulatory changes.

•             Contribute to the development and review of SOPs and work instructions based on updates from regulatory intelligence process.

Required Qualifications & ExperienceEducation

•             Bachelor’s degree (minimum) in Pharmacy, Life Sciences or a related field.

•             Regulatory Affairs certification (e.g., RAC from RAPS) is highly desirable.

Experience

•             Minimum 3 years of experience in Regulatory Affairs, Compliance, or a related GxP function within the pharmaceutical or healthcare industry.

•             Demonstrated experience in regulatory intelligence activities, including monitoring, assessment, and reporting.

•             Prior experience covering African markets or multi-country regulatory environments is strongly preferred.

•             Familiarity with GxP regulatory frameworks across multiple functional areas (RA, PV, QA, Supply Chain, etc.).

Skills & Competencies

•             Analytical Thinking: Ability to critically evaluate complex regulatory documents and extract actionable intelligence.

•             Communication Skills: Exceptional written and verbal communication skills; ability to translate technical regulatory content for diverse audiences.

•             Attention to Detail: High level of accuracy in interpreting and reporting regulatory requirements.

•             Organizational Skills: Ability to manage large volumes of information simultaneously.

•             Digital Proficiency: Experience with regulatory intelligence tools, databases, and document management systems.

•             Multilingual Ability: Proficiency in English is essential; proficiency in French and/or Portuguese is an advantage.

•             Collaboration: Proven ability to work effectively with cross-functional and geographically dispersed teams.

Core Values Alignment

The successful candidate will demonstrate alignment with Company’s core values:

·         Accountability – Taking ownership of regulatory intelligence quality and timeliness

·         Ambition – Driving continuous improvement in intelligence processes

·         Responsibility – Ensuring that GxP compliance is supported by accurate intelligence

·         Engagement – Actively collaborating with teams and external stakeholders