Your newpany
We are partnering with a highly regarded regulatory affairs consultancy that is seeking an experienced Regulatory Affairs Consultant to support clients with strategic regulatory activities across the Middle East and North Africa (MENA) region.This is a senior-level role offering the opportunity to leadplex regulatory strategies, work closely with global project teams, and play a key role in lifecycle management and safety submissions across multiple markets.
Your new role
The Regulatory Affairs Consultant MENA will be responsible formunicating and implementing regulatory strategies to support product lifecycle management (LCM) and ensurepliance with evolving global and regional requirements. You will act as a trusted regulatory advisor to project teams, clients, and affiliates, ensuring regulatory activities are executed efficiently and strategically across the MENA region.Key Responsibilities
1. Develop and implement regulatory strategies to support new submissions and lifecycle management activities, ensuring ongoingpliance with global and regional requirements.
2. Provide strategic regulatory guidance to cross-functional project teams and ensure availability and maintenance of current regulatory documentation
3. Lead and oversee regulatory operational activities to ensure timely, high-quality submission delivery
4. Manage themunication, development, and execution of MENA regulatory strategies for Safety Update submissions and LCM activities
5. Take accountability for the execution of lifecycle management submission packages across all MENA markets.
6. Collaborate closely with affiliates, business partners, artwork teams, pharmacovigilance, and other cross-functional stakeholders to maintain supply continuity and prioritise patient safety.
7. Lead and participate in regular cross-functional meetings to ensure alignment, transparency, and effective information exchange.
8. Ensure labelling submissions are delivered in line with CDSpliant timelines
9. Contribute to continuous improvement initiatives and process enhancements as required
What you'll need to succeed
10. Senior regulatory professional with strong experience managing regulatory strategies and submissions across MENA markets
11. Proven ability to leadplex lifecycle management and safety-related regulatory activities
12. Strong stakeholder management skills, with experience working across affiliates, partners, and cross-functional global teams
13. Strategic mindsetbined with hands-on execution capability
14. Excellentmunication skills and the confidence to act as a regulatory subject-matter expert
What you'll get in return
Remote working, outside IR35