Regulatory CMC

Our client is developing a monoclonal antibody (mAb) therapy for migraine and other headache disorders. They need a senior Regulatory CMC expert who can set strategy and also write the technical content.

The consultant will own the CMC regulatory package for the IND. They will then help prepare the CMC strategy and documentation as the program moves toward Phase III. It suits someone who wants a focused, high-impact part-time engagement.

• Lead regulatory CMC strategy for a monoclonal antibody program, covering FDA and EMA requirements.
• Prepare and coordinate the CMC package for the IND filing.
• Author and review CTD Module 3 sections for drug substance and drug product.
• Support the CMC regulatory transition to Phase III, including gap assessments and phase-appropriate planning.
• Advise on the regulatory impact of manufacturing, analytical and process changes.
• Review CDMO-generated data and reports for submission readiness.
• Prepare CMC content for health authority meetings and responses to information requests.
• Work closely with internal CMC, Quality and Regulatory stakeholders.

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Significant Regulatory CMC experience with biologics (e.g., monoclonal antibodies or recombinant proteins).
• Strategic Regulatory CMC background, not only operational or publishing support.
• Hands-on experience preparing CMC packages for IND submissions.
• Proven technical writing of CTD Module 3 sections.
• Experience supporting CMC through late-stage development, ideally the transition to Phase III.
• Working knowledge of US and EU CMC regulations and ICH guidelines.
• Able to work independently and deliver within a part-time, fractional schedule.
• Based on the US East Coast.

• Experience in neuroscience or migraine programs.
• Experience with BLA/MAA preparation or end-of-Phase II meetings.
• Background working with CDMOs in a small biotech or consulting setting.