Regulatory CMC Director

Job title: Regulatory CMC Director

A biopharmaceutical company in Berkshire are seeking a Regulatory CMC Director to join their growing team. They will have overall responsibility and leadership for the strategy and execution of CMC-Regulatory filings including authoring, coordination, review, and approval for the assigned product portfolio

Responsibilities:

  • Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders.
  • Ensures all CMC-Regulatory dossiers data remain relevant, compliant, current and aligned with global regulatory processes and practices.
  • Assesses CMC-Regulatory impact of all changes relating to the allocated product portfolio, propose and communicate prioritization of changes to reflect company/department objectives.
  • Ensure the team delivers timely submission-ready CMC dossiers for the allocated product portfolio.
  • Line Management of two direct reports in different locations.

Requirements:

  • Extensive Regulatory CMC experience.
  • Experience should include clinical development (IND/IMPD), registration and post-approval activities in US, EU and major Intercontinental markets e.g. China, Japan.
  • Demonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.
  • Previous line management experience would be beneficial.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk

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