Director of Regulatory Affairs CMC

BlueRock Therapeutics
United States, Massachusetts, Cambridge
238 Main Street (Show on map)
Jan 15, 2025
Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique *cell+gene* platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases. The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel *cell+gene* platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. 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. #LI-AL1 BlueRock Therapeutics Company Culture Highlights Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023 Winner of Comparably's Award for Best Company for Diversity 2022 Winner of Comparably's Award for Best Company for Women 2022 Winner of Comparably's Award for Best CEO 2022 BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably. Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/ Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.