Are you ready to lead regional regulatory strategy and guide multiple products as the next Senior Manager of Regulatory Affairs?
Proclinical is seeking a Senior Manager in Regulatory Affairs to support one or more products from a regional regulatory perspective. In this role, you will collaborate with global and regional teams to develop and execute regulatory strategies, ensuring compliance and effective agency interactions. This position involves guiding product development, managing submissions, and maintaining licenses for investigational and approved medicinal products.
Responsibilities:
1. Advise the Global Regulatory Team (GRT) on regional considerations and ensure alignment with regional needs.
2. Plan and manage regulatory submissions, including clinical trial and marketing applications, in compliance with global and local requirements.
3. Develop and implement regional regulatory strategies and processes in line with national legislation.
4. Lead the creation of regional regulatory documents and participate in meetings aligned with GRT strategy.
5. Provide guidance on regional regulatory mechanisms to optimize product development, such as expedited studies, orphan drug designations, and paediatric plans.
6. Collaborate with the Labelling Working Group to develop and negotiate regional product labels.
7. Coordinate responses to regulatory authority requests and communicate strategies effectively.
8. Assess regulatory risks and success likelihood, providing insights to the GRT and management.
9. Ensure compliance with regulatory commitments, including post-marketing commitments and paediatric plans.
10. Maintain awareness of evolving legislation, regulatory policies, and competitor activities.
11. Act as a point of contact for regulatory agencies, documenting and communicating outcomes of interactions.
12. Support collaboration between regional leads and management to address program issues.
13. Provide leadership and direction to assigned team members, prioritizing resources effectively.
Key Skills and Requirements:
14. Strong knowledge of regional regulatory legislation and procedures, including CTAs, MAs, post-approval changes, extensions, and renewals.
15. Experience with regulatory processes and compliance in the pharmaceutical or biotechnology industry.
16. Comprehensive understanding of drug development and regulatory touchpoints.
17. Ability to resolve conflicts and develop actionable solutions.
18. Awareness of cultural sensitivities and ability to work across international borders.
19. Excellent communication and collaboration skills to align with global and regional teams.
20. Familiarity with regulatory research and ability to evaluate the impact of regulations and guidance.