Associate Director, Regulatory CMC

1 settimana fa

Milano, Lombardia, Italia Singular: Building Brilliant Biotechs A tempo pieno 60.000 € - 120.000 € all'ano

Associate Director – Regulatory CMC

Are you a CMC regulatory expert with experience across product development, submissions, and lifecycle management? This is an opportunity to lead global CMC regulatory strategy for a biopharma organisation advancing innovative therapies across multiple modalities.

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 organisation integrates R&D, regulatory, and manufacturing excellence to bring novel therapies from discovery to market.

As part of the Global Regulatory Affairs function, you'll join a collaborative, high-performing team driving Chemistry, Manufacturing, and Controls (CMC) regulatory excellence across small molecule, biologic, and combination product portfolios.

THE ROLE

As Associate Director – Regulatory CMC, you will lead the development and execution of global CMC regulatory strategies across early development, registration, and post-approval stages. You'll act as the primary regulatory point of contact for CMC programmes, 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 which combines fast paced decision making with tremendous scientific opportunity giving you the chance to make a huge impact in this role.

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.

ABOUT YOU

  • You'll be successful in this role if you have:
  • At least 8–10 years' 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.
  • Familiarity with combination product registration in EU and US markets.

You must be based in Europe for this role.

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

I look forward to hearing from you

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