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.