DIRECTOR, REGULATORY AFFAIRS CMC

Company: Gritstone Oncology
Location: Pleasanton
Posted on: September 17, 2020

Job Description:

Represent Regulatory CMC on CMC project teams and develop and lead regulatory CMC strategy discussions.

Lead and drive CMC content for submission activities for pre-IND documents, original INDs, and IND amendments; lead strategy and preparation efforts and FDA interaction on End of Phase 2 CMC Meeting; and lead strategy and preparation for BLA-readiness.

Prepare and support Investigational Medicinal Product Dossiers (IMPDs) in support of EU, UK, Canada, and ROW clinical trials.

Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders.

Maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant topics to cross-functional stakeholders.

Review and assess the regulatory CMC impact of change controls and provide guidance to functional areas to ensure compliance, and lead CMC team through preparation and submission of necessary amendments resulting from change controls.

Participate in CMC meetings with Regulatory authorities and lead response activities for information requests from various agencies.

Position requires up to 15% domestic travel.

MINIMUM REQUIREMENTS:

Bachelor’s Degree in Life Sciences, Biology, Health Care Management, or a related field or the foreign degree equivalent; and 8 years of progressive, post-baccalaureate experience managing regulatory CMC aspects of biologic products, including 5 years of experience with analytical characterization and comparability and release tests; 5 years of experience with process scale-up, transfer, and validation; 8 years of experience with GMP manufacturing facility and equipment; 5 years of experience preparing Investigational New Drug Applications or Clinical Trial Applications (including Investigational Medicinal Product Dossier); 5 years of experience leading interactions with the US FDA and/or other federal health authorities; and experience preparing at least 1 New Drug Application and/or Marketing Authorization (Module 3). Experience may be gained concurrently.

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Keywords: Gritstone Oncology, Pleasanton , DIRECTOR, REGULATORY AFFAIRS CMC, Other , Pleasanton, California