Senior Associate Regulatory Affairs
Join our team as a Senior Associate Regulatory Affairs and play a vital role in supporting the development and lifecycle management of innovative pharmaceutical products. This exciting position offers an opportunity to work within a dynamic regulatory environment, collaborating closely with global teams to ensure compliance and successful product approvals in the UK & Ireland. Based mainly remotely in Cambridge, you will contribute to impactful projects that support patient health while developing your career in regulatory affairs.
What You’ll Need to Succeed
- Broad regulatory affairs experience, particularly within a UK affiliate setting, covering clinical trials, post-marketing, lifecycle management, and labelling.
- Strong knowledge of regulatory principles, SOPs, and policies related to medicinal products.
- Excellent communication skills, capable of liaising with regulatory agencies and cross-functional teams.
- Familiarity with local legislation, and ideally, experience using Veeva RIM.
- Ability to manage multiple tasks efficiently, supporting regulatory submissions and compliance activities.
Nice to Have
- Experience with Veeva RIM or similar regulatory information management systems.
- Previous involvement in regulatory activities related to urgent safety communications or agency commitments.
- Additional knowledge of national legislation affecting pharmaceutical regulations in the UK & Ireland.
Preferred Education and Experience
- Master’s degree in a scientific discipline or Bachelor’s degree with at least 2 years of relevant regulatory experience.
- Current UK affiliate experience is essential, with candidates available to start quickly (within 4 weeks preferred).
Other Requirements
- This is a 12-month contract role with the flexibility of remote work, requiring attendance in Cambridge once per month for team meetings.
- Candidates must be in a UK & Ireland affiliate role at the time of application.
- Ability to work effectively in a collaborative environment, supporting regulatory strategies for low to medium complexity programs.
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Senior Associate Regulatory Affairs in Cambridge employer: Planet Pharma
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