Job Description

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?

Ourfoundational scienceharnesses 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.

Description of Position:

This position reports into the Senior Vice President of Regulatory Affairs and Medical Writing. The incumbent is responsible for directing multiple innovative global CMC strategies for product development and approval, and providing regulatory CMC leadership and guidance to CMC teams developing cell and gene therapy products. The VP will build an internal team and relationships with internal stakeholders as well as external consultants/contractors, as necessary to support regulatory activities and provide leadership and guidance to the organization on global CMC matters. Experience and knowledge of global regulations for the development of cell therapy products is required, and any experience in the neurology and/or ophthalmology therapeutic areas is desired.

• Develop strategic vision for Regulatory CMC.
• Provide Regulatory CMC leadership in corporate and policy setting teams and committees.
• Represent Regulatory CMC on and/or lead matrix teamsfor cell therapy pipeline products.
• Independently provide strategic and innovative 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).
• Lead Health Authority engagements for CMC submissions and CMC-related issues.
• Identify, communicate, and propose resolutions to routine and complex strategic issues
• Monitor and interpret global regulations/guidance and analyze appropriate regulatory agency activities in areas of interest (e.g., cell therapy) to the company. Anticipate and communicate possible regulatory paradigm shifts, identifying regulatory opportunities and risks and provide updates to Executive Management.
• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. Manage relationships with diverse teams in a collaborative manner.
• Provide input to Executive Teams; might be a member of the teams.
• Advise on submissions and evaluate the content and adequacy of regulatory submissions; identify deficiencies requiring further resolution.
• Review and provide regulatory assessments on change controls.
• Mentor/instruct and provide guidance to internal and external in-direct reports including consultants and CROs as well as plan, assign and direct work; manage competing priorities as appropriate.
• Drive utilization of electronic systems for dossier creation and tracking.
• Support departmental initiatives, including special projects, budgeting, and authoring departmental documents.

• 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 12-15 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 global 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 or gene 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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