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
