Regulatory Affairs Manager

2 days ago

Johannesburg, South Africa The Focus Group Full time

The Focus Group Johannesburg, South Africa 20 May 2025 Mid 1000000 - 1800000 Full Time Cost to Company 4 years - 6 years Skills Pharmaceutical Medical Healthcare Regulatory Rules Management Negotiation Presentations Industries Pharmaceutical Medical Healthcare Job Description
**Client**: Pharmaceutical Multinational
We are hiring a Regulatory Affairs Manager responsible for the management and execution of regulatory activities for South Africa (with extension into SSA). The job holder performs quality regulatory activities in compliance with internal and external requirements to support business continuity.
The job holder will be based in Johannesburg, South Africa and will report to the Head of Regulatory Affairs.

**Responsibilities**:
Timely execution and management of local Regulatory Affairs activities in compliance with Regional RA strategies and local business priorities.
Maintain product registrations and RA databases while ensuring business continuity in compliance with internal and external regulations and requirements.
Collaborate with local health authorities to support CLIENTS’s business in the operating unit
Provide regular intelligence on changes in regulatory environment, competitor activity and opportunities to enable the business realize risk or opportunities arising in the RA environment.
Participate in budget exercises and collaborate cross-functionally and ensure all stakeholders are updated on relevant RA topics.
Establish a strong partnership and interact with the local authorities in the country; Maintain efficient relationships with related Regulatory service Providers (local agents and vendors).
Conduct agreed actions for local projects.
Provide support to the country RA head on local, regional and global projects.
**Job Requirements**:
Bachelors in Pharmacy / Masters is an advantage
4 - 6 years Regulatory experience in a multi-national Pharmaceutical company; Human Pharma experience preferred.
Significant experience of direct interactions with Regulatory Authorities.
People management experience is an asset.
Regional or International working experience is a plus.
**Skills**:
Strong business acumen and operational excellence
Innovative and critical thinking
Effective negotiation skills
Demonstration of effective cross-functional collaboration
Problem solving and Decision making
Project management
Good Presentation skills
Time management
**Registered body**: SAPC or South African Pharmacy Council

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