Regulatory Affairs Manager
The Focus Group
- R Undisclosed
- Permanent Intermediate position
-
Johannesburg
- Posted 20 May 2025 by The Focus Group
- Expires in 34 days
-
Job 2611205
About the position
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.
Job 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
Desired Skills:
- Healthcare
- Management
- Medical
- Negotiation
- Pharmaceutical
- Presentations
- Regulatory Rules
The Focus Group
About the agency
THE FOCUS GROUP was formed in 1989 and has offices in Johannesburg and Cape Town. We are a full service Human Resource Consulting Company, encompassing Black Empowerment joint venture partner Focus Kamoso, and offering a comprehensive range of integrated recruitment, assessment, employee relations, training and development, HR, employee benefit and payroll management services to a wide range of South African, African and international business organisations.
Our commitment is to enter into a partnership with you, the Client, which adds value to your business and profit to your bottom line, by tailoring solutions that assist you to
• Source, assess and select the best possible human resources.
• Design and implement competency based training programmes, which ensure that your employees are capable of delivering the service excellence that your clients demand, and the competitive edge which you seek to maintain.
• Create a business environment in which you manage change to your advantage and an organisational climate that allows your team to perform to its maximum potential.
• Design employee benefit and remuneration structures which ensure that your people take ownership of your business and which protect you against losing your most valuable resource to your competition.
• Implement an employee relations framework that promotes workplace harmony and minimises the occurrence of disruptive legal disputes.
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