CMC Reg Affairs Specialist

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.