Regulatory Affairs Portfolio Manager
3 days ago
Job Title: Regulatory Portfolio Manager
Job Type: Contract
Location: Uxbridge, UK – Hybrid/Remote
Rate: Up to £45.60 per hour
We are seeking a highly skilled Regulatory Portfolio Manager to join our team at Cpl Life Sciences. As a key member of our Regulatory Affairs team, 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 deliver and execute the optimal regulatory strategy for assigned assets.
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan, including tracking key regulatory milestones and liaising cross-functionally to generate periodic internal milestone reports.
- Maintain global submission plans, including oversight of interdependencies across regions for timely execution aligned with the asset's priorities.
- Communicate status and timeline changes, and provide operational support to the GRL on strategic global regulatory documents, including the Regulatory Strategy Plan.
- Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally, and review prior health authority queries to guide response development.
Requirements:
- MUST have a suitable degree in life sciences.
- 3/5 years of experience in Regulatory Affairs.
- Strong Regulatory Strategy experience.
- Ideally someone who has worked on both pre and post-approval.
- Full right to work in the UK.
For more information, please contact us.
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