Job Description
This position is reports into the Vice President of Regulatory Affairs and Medical Writing. The incumbent is responsible for providing regulatory CMC leadership and guidance to regulatory strategy and CMC teams developing cell and gene therapy products, including generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in the U.S. and multiple international territories. This role involves working closely with technical CMC teams, program teams, as well as sits on the Global Regulatory Strategy subteam. Experience in neurology, ophthalmology and/or cardiovascular therapeutic areas and knowledge of global regulations for the development of cell therapy products is desired.
Responsibilities: - Represent regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products.
- Independently provide strategic guidance/input related to current regulatory requirements and expectations for cell and gene therapy CMC in support of clinical trial and marketing applications.
- Independently manage and prioritize multiple complex projects.
- Drive workflows related to Health Agency interactions (ie, briefing documents and responses to questions).
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from departmental head on complex topics (ie, comparability, specification changes, etc.).
- Identify, communicate, and propose resolutions to routine and complex strategic issues
- Interpret global regulations and guidance. Identify regulatory opportunities and risks.
- Anticipate and communicate possible regulatory paradigm shifts.
- Review and provide regulatory assessments on change controls.
- Prepare and manage CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documents
- Mange relationships with diverse teams in a collaborative manner.
- Utilize electronic systems for dossier creation and tracking.
- Support departmental initiatives, including special projects, budgeting, and authoring departmental documents
Minimum Requirements: - The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
- At least 8-10 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals and/or cell and gene therapy products (preferred).
- Experience with combination products and device filing experience also preferred.
- Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.
- Lead regulatory CMC discussions with global regulatory authorities.
- Experience in development, manufacturing and testing of cell therapeutics is highly desired.
- Experience in supporting the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.
- Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.
- Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations.
- Excellent written and communication skills with attention to detail. Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission.
- Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 25% is required.
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