Director, Regulatory Cmc

About the Company

This pioneering biopharmaceutical company is committed to transforming patient outcomes through cutting‑edge science in ophthalmology, neuroscience, and rare diseases. Operating globally, the organization integrates R&D, regulatory, and manufacturing excellence to bring novel therapies from discovery to market.

The Role

As Director – Regulatory CMC, you will lead the intersection of regulatory and CMC focusing on regulatory submissions, registration, and post‑approval stages. You will act as a primary regulatory point of contact for CMC programs, ensuring timely submissions, compliance with GMP and ICH guidelines, and proactive engagement with health authorities. You will have the opportunity to work in a collaborative environment that combines fast‑paced decision‑making with tremendous scientific opportunity.

Key Responsibilities

• Develop and implement CMC regulatory strategies for IND, IMPD, NDA, BLA, MAA, and variation filings.
• Lead the preparation, review, and submission of CMC sections (Modules 2 & 3) of the CTD, ensuring data integrity and consistency.
• Serve as the CMC regulatory lead on cross‑functional teams, collaborating with CMC, QA, QC, manufacturing, and external partners.

Qualifications

• At least 8–10 years of experience in regulatory CMC roles within the pharmaceutical or biotech industry.
• Proven experience in preparing regulatory submissions (CTD/eCTD) and managing pre‑ and post‑approval CMC activities.
• Must be based in Europe.

How to Apply

If you're ready to take a leading role in shaping global CMC regulatory strategy and bringing novel therapies to patients, apply now.