Manager, Regulatory Affairs Strategy

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.
We are seeking a highly motivated individual to join the BlueRock team as a Manager/ Senior Manager of Regulatory Affairs reporting into the Director of Regulatory Affairs This role will be responsible for supporting regulatory activities from early development through BLA, while ensuring compliance with all global regulatory standards and guidelines. This role will develop and/or execute regulatory strategies and assigned projects to support global clinical development, approval, and commercialization.  This role will manage the preparation and submission of regulatory documents. Individuals will also maintain awareness of the global regulatory environment for cell and gene therapies including accelerated development opportunities with the potential to accelerate assigned programs.Responsibilities:

Solid knowledge of FDA regulations and ICH guidelines with other regions a plus (EMA, LATAM, Etc)

In conjunction with the Regulatory Strategy Lead, provide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathways

Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare regulatory submissions (eg, meeting requests, briefing documents, IND/CTA filings, marketing applications, designation requests, etc...).

Oversee content development, organization, and coordination of cross functional regulatory submissions (e.g., INDs, CTAs, BLA,  etc...).

Learn and maintain detailed knowledge of the evolving global regulatory landscape relevant for cell therapies and regenerative medicine including accelerated review programs. Assess the impact of new regulations/guidance on internal programs, and communicate relevant changes to internal stakeholders.

Contribute to regulatory department initiatives to develop procedures and working practices

Minimum Requirements:

BS or MS degree in a  scientific discipline or related field is required; MS/PhD preferred.

Minimum of 5 years of experience in the pharmaceutical or biotechnology industry including at least 3 years of experience within the Regulatory Affairs function.

Regulatory experience with INDs and/or CTAs. Life cycle experience a plus. Some experience in cell or gene therapy  preferred. International regulatory experience a plus

Experience in preparing documents for regulatory filings including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with health authorities

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

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

Experience supporting the development and implementation of complex regulatory strategies.

Experience assisting with the development of briefing documents and interfacing with regulatory agencies.

Strong interpersonal skills and the ability to collaborate effectively with various technical area experts.

Excellent written and oral 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 20% is required.

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BlueRock Therapeutics Company Culture HighlightsWinner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023Winner 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-therapeuticsFollow 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.