Associate Director, Regulatory CMC

Associate Director, Regulatory CMC

BioMarin

London, United Kingdom

The position requires knowledge and experience of biologics and/or pharmaceuticals and preferably gene therapy medicinal products. The incumbent must possess technical expertise in the area of responsibility and demonstrate effective problem solving, strong understanding of global regulatory affairs submissions and management skills and the ability to prioritize multiple tasks.

The Regulatory CMC Global Product Lead develops and communicates CMC regulatory strategies that are in alignment with project goals and timelines. This includes formulating the global CMC strategy for the Global Regulatory Plan, with input from regional regulatory representatives and CMC SMEs; preparing CMC documentation to support high quality, right first time global regulatory filings including new MAAs, renewals and post-approval submissions, including liaising with GRT regional representatives and relevant SMEs to draft technical content for CMC submissions from development through commercial to support life-cycle management of biotech products.

• Works closely with the BioMarin International Ltd (BIL) Quality assurance, Quality Control and Manufacturing groups to assure the relevant product and regulatory expectations are met;
• (as needed) Manage a small team of regulatory CMC professionals or contract workers in the UK or at the BIL site;
• Lead regulatory CMC support for impact assessment to change control, deviation and cGMP inspection readiness at BioMarin sites;
• Coordinate and track regulatory commitments related to drug substance and drug product technology transfers;
• Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities;
• Demonstrate initiative and have the ability to work independently and collaboratively in a team structure and in a global organization.

Education:

• Minimum requirement is for a bachelor’s degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.

Experience:

• Minimum of 10 years of Regulatory Affairs, CMC experience;
• Proven experience in a leadership role with strong management skills and business acumen;
• Experience with people management preferred;
• Understanding of drug development, technology transfers and working under accelerated timelines;
• Outstanding interpersonal and communication (written and verbal) skills is required;
• Strong writing and editing skills for technical documentation;
• Proficient with computer and standard software programs.

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