RA Associate - Regulatory Affairs (ESA)

RA Associate - Regulatory Affairs (ESA)

Location: East and Southern Africa

Job Description:

Join our team as an RA Associate, where you'll support regulatory maintenance activities for our registered base portfolio, ensuring optimization and compliance. You'll manage regulatory matters across various spheres of activity such as Registration, Production, Supply Chain, and Quality Assurance. Your role involves engagement with internal and external stakeholders, monitoring regulatory requirements, and communication of policy intelligence.

Key Responsibilities:

Support submissions and approvals of quality/CMC variations

Manage life cycle maintenance activities for approved products/variations

Engage and collaborate with internal and external stakeholders

Develop and maintain dashboards and trackers to improve regulatory processes

Monitor and communicate emerging regulatory requirements and policy intelligence

Ensure compliance with global and local/regional processes

Requirements

Requirements:

Education: B.Pharm or life sciences degree or equivalent

Experience: Minimum 1-3 years' experience in pharmaceutical regulatory affairs environment

Languages: Fluency in English as a business language; Portuguese/French is a plus

Computer Skills: Proficiency in MS Office (Excel, PowerPoint)

Qualifications:

Minimum 1-3 years' experience in pharmaceutical regulatory affairs environment

Knowledge of Regulatory requirements for Medicines in the East and/or Southern Africa countries

A good understanding of pharmacology, pharmaceutical and clinical data and the pharmaceutical market

Proficiency in analytical, organizational, and communication skills

Detail-oriented with the ability to prioritize workload and meet deadlines

Proactive, people-orientated, with organizational awareness

How to Apply: If you meet the qualifications please submit your application.