CMC Reg Affairs Specialist
Copilot said:
CMC Regulatory Affairs Specialist
Location: Copenhagen, Denmark
Contract: 6 Months Initial Contract (Extension Likely)
Start Date: September 2026
We are supporting an innovative pharmaceutical company in Copenhagen seeking a CMC Regulatory Affairs Specialist to support a key late-stage development programme.
This is an excellent opportunity to join a high-performing regulatory team and play a critical role in the preparation and execution of CMC regulatory activities across the European market.
Key Responsibilities
- Support CMC regulatory strategy for late-stage development products.
- Prepare, review, and coordinate regulatory submissions and variations.
- Ensure compliance with European regulatory requirements and guidelines.
- Collaborate with cross-functional teams across Regulatory Affairs, CMC, Quality, and Manufacturing.
- Support interactions with health authorities as required.
- Contribute to submission planning and regulatory risk assessments.
Requirements
- Proven experience within CMC Regulatory Affairs in the pharmaceutical or biotechnology industry.
- Strong knowledge of European regulatory requirements.
- Experience supporting late-stage development programmes.
- Familiarity with CTD/eCTD dossier preparation and lifecycle management activities.
- Strong stakeholder management and communication skills.
- Ability to work effectively within a fast-paced, cross-functional environment.
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