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Regulatory Portfolio Manager
2 months ago
Cpl Life Sciences is seeking a highly skilled Regulatory Portfolio Manager to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in delivering and executing the optimal regulatory strategy for assigned assets.
Key Responsibilities:- Partner with the Global Regulatory Lead and wider Global Regulatory Sub-Team to develop and maintain the asset's global regulatory book of work and Global Submission Plan.
- Track key regulatory milestones and maintain global submission plans, ensuring timely execution aligned with the asset's priorities.
- Provide operational support to the GRL on strategic global regulatory documents, including the Regulatory Strategy Plan.
- Coordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
- Represent the Global Regulatory Lead in team meetings as needed.
- Degree or equivalent in a healthcare-related field.
- Direct regulatory experience with developing knowledge of US and/or EU procedures.
- Ability to lead through influence and build alignment with stakeholders to deliver projects to plan.
- 3-5 years of experience in Regulatory Affairs.
Why Cpl Life Sciences? We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and experienced Regulatory Portfolio Manager looking for a new challenge, we encourage you to apply.
