Regulatory Affairs Manager
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Key skills for this role
Role Overview
The Regulatory Affairs Manager supports products across five Gulf markets.
The role plans and executes regulatory strategies for medium-complexity programs with medium business impact.
The role aligns local regulatory requirements with corporate standards and maintains regulatory compliance.
Key Skills for This Role
Full Job Posting
Role overview
The Regulatory Affairs Manager supports products across five Gulf markets.
The role plans and executes regulatory strategies for medium-complexity programs with medium business impact.
The role aligns local regulatory requirements with corporate standards and maintains regulatory compliance.
Key responsibilities
- Contribute to marketing authorization and lifecycle maintenance filing plans.
- Execute country filing plans and ensure timely, compliant submissions.
- Provide local regulatory input to product strategies and approval mechanisms.
- Review promotional, non-promotional, patient support, digital health, and software materials from a regulatory perspective.
- Gather and communicate competitive regulatory intelligence.
- Maintain regulatory data in Veeva RIM, the CPP tool, and regulatory intelligence databases.
- Monitor legislation, policy, technical guidance, distributor management, and trade association developments.
- Perform regulatory research supporting product development, registration, and lifecycle decisions.
Health authority interactions
- Act as a point of contact with regulatory agencies for local obligations.
- Participate in preparing and conducting local health authority interactions.
Collaboration and ways of working
Work with country, affiliate, hub, international, and global regulatory colleagues on strategy and product lifecycle activities.
Exchange regulatory intelligence and advise cross-functional teams on local considerations.
Support consistent procedures, process improvements, initiatives, and training.
Mentor and advise local regulatory representatives at more junior levels.
Requirements
- Bring sound judgment, curiosity, adaptability, and a solution-oriented mindset to regulatory work in a dynamic environment.
- Provide regulatory advice and subject-matter expertise across assigned Gulf markets and products.
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