Regulatory Portfolio Manager
4 dni temu
We are seeking an ambitious Regulatory Project Manager to drive the development of regulatory strategies and their execution for assigned assets consistent with strategic activities for our Classic & Established Product (CEP) portfolio.
This role requires ensuring compliance with both internal processes and procedures, as well as regulatory requirements.
Responsibilities- Act as Global Regulatory Lead to drive matrix team engagement for CEP portfolio assets and take ownership of life cycle maintenance, including discontinuation of Marketing Authorizations (MAs).
- Lead communication with regulatory agencies, specifically be the main point of contact with the European Medicines Agency and other Local Health Authorities for National, Centralised and Mutual Recognition procedures products.
- Ensure that regulatory strategies deliver commercial and supply chain project needs while considering local market regulatory needs.
- Cultivate and sustain productive relationships with internal stakeholders, including labelling, CMC, medical, commercial, supply chain, and clinical teams.
- Take proactive initiatives to identify and escalate crucial issues early and contribute to crafting solutions.
- Ensure compliance with global/regional lifecycle requirements and delivery of health authority commitments.
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