Reporting to the Vice President of Regulatory Affairs, the Director, CMC Regulatory Affairs is responsible for overseeing the development and implementation of global regulatory CMC strategies for development projects. The Director will provide regulatory CMC leadership across projects and teams and will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions. Responsibilities include: Serve as a Regulatory CMC ... more details
Reporting to the Vice President of Regulatory Affairs, the Director, CMC Regulatory Affairs is responsible for overseeing the development and implementation of global regulatory CMC strategies for development projects. The Director will provide regulatory CMC leadership across projects and teams and will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions.
Responsibilities include:
Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams.
Develop and execute global CMC regulatory strategies for investigational products in gene therapy.
Coordinate and author/review high-quality CMC submissions to regulatory agencies, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, and briefing documents for Health Authority meetings as well as other relevant CMC documents.
Lead CMC related interactions with regulatory agencies.
Collaborate with internal CMC staff, consultants, QA colleagues, and CROs/CMOs to document and resolve technical manufacturing issues.
Maintain knowledge of global CMC regulatory requirements to advise teams on regulations, guidelines, procedures and policies relating to development, registration, and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.
Support the Vice President, Regulatory Affairs, with other regulatory activities as directed.
Requirements / Qualifications:
Master’s degree in chemistry, biochemistry, or pharmacy with a minimum of 10-12 years of experience in global CMC Regulatory Affairs in the pharmaceutical/biotech industry, supporting both development projects and marketed products with evidence of successful CMC submissions (e.g. INDs,NDAs, briefing packages)
Strong background in cell and gene therapy required
Strategic thinking and problem solver
Excellent written and oral communication skills, including writing of CMC regulatory documents
Knowledge of FDA and ICH CMC regulations and guidelines, EU and other regional CMC regulations desirable
Strong knowledge of eCTD elements and structure
Demonstrated ability to work effectively through cross-functional team to achieve results
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