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
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
Position requires up to 15% domestic travel.
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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