Associate Director of Regulatory Affairs CMC

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 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, 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.  Expertise and knowledge of global regulations and guidance 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 expectation for cell and gene therapy 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 in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in product development.

At least 6-10 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products (preferred).

Minimum of 4 years of direct experience interfacing with regulatory authorities

Experience in cell and gene therapy strongly preferred.

Experience with combination products and device filing experience also preferred.

International regulatory experience desired.

Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA, and NDA/BLA/MAA.

Lead regulatory CMC discussions with global regulatory authorities.

Experience and knowledge in the preparation of electronic submissions following eCTD format

Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.

Experience in development, manufacturing and testing of cell therapeutics is highly desirable.

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.

Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 25% is required.

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BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock 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
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.