Regulatory CMC Director

5 days ago


Cork, Cork, Ireland Elusav Recruitment Full time

Elusav recruitment have an exciting opportunity for a Director, Regulatory CMC with a leading Global Biopharmaceutical in Cork, Ireland.

This role is responsible for ensuring the relevant product and regulatory expectations are met through collaboration with the company's Quality assurance, Quality Control and Manufacturing groups.

The successful candidate will act as the primary regulatory CMC contact at the company site comprising end to end manufacturing of biologicals (drug substance, drug product, QC testing and packaging operations).

Key responsibilities include:

  • Working on site for at least 2 days a week
  • Managing a small team of regulatory CMC professionals at the site
  • Primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe, as required
  • Leading global marketing authorisations, renewals and post-approval changes for biological products, drug-device combination products and/or small molecules

Requirements:

  • Minimum requirement is for a bachelor's degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science
  • Minimum of 8 years of Regulatory Affairs, CMC experience
  • Proven experience in a leadership role with strong management skills and business acumen


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