Associate Director, Regulatory Affairs-CMC
About The Position
Associate Director, Regulatory Affairs - CMC (BlueRock Therapeutics, LP; Cambridge, MA): The Associate Director, Regulatory Affairs - CMC is responsible for providing regulatory leadership and guidance to CMC teams developing cell and gene therapy products, including the oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories. This role involves working closely with technical CMC teams in USA and Canada, project teams, as well as serving as point for interactions with global health authorities to achieve alignment on the regulatory strategies to advance the BlueRock portfolio.
Requirements
- Bachelorâs degree or equivalent in Regulatory Science or related field plus 6 years of experience in Regulatory Affairs, CMC.
- Experience in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products.
- Direct experience interfacing with regulatory authorities.
- Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA and NDA/BLA/MAA.
- Ability to lead regulatory CMC discussions with global regulatory authorities.
- Experience preparing electronic submissions following eCTD format.
- Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
- Experience in leading 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.
Responsibilities
- Representing regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products.
- Independently providing strategic guidance/input related to current regulatory requirements and expectation for cell and gene therapy clinical trial and marketing applications.
- Independently managing and prioritizing multiple complex projects.
- Driving workflows related to Health Agency interactions (ie, briefing documents and responses to questions).
- Interfacing 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.).
- Identifying, communicating, and proposing resolutions to routine and complex strategic issues Interpret global regulations and guidance.
- Identifying regulatory opportunities and risks.
- Anticipating and communicating possible regulatory paradigm shifts.
- Reviewing and providing regulatory assessments on change controls.
- Preparing and managing CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documents.
- Managing relationships with diverse teams in a collaborative manner.
- Utilizing electronic systems for dossier creation and tracking.
- Supporting departmental initiatives, including special projects, budgeting, and authoring departmental documents.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
