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