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Director, Regulatory Affairs at BlueRock Therapeutics
Cambridge, MA, US

Who is BlueRock?

BlueRock is a leading engineered cell therapy company using its unique CELL+GENETM 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.

Description of Position:

The Director of Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for products in the BlueRock portfolio spanning numerous indications. The individual will interface with a diverse cross-functional team to ensure regulatory strategy is aligned with the overall corporate strategy. BlueRock has a dynamic setting and offers the opportunity to interact with key functions that sit at the intersection of the complex interplay between major health authorities. The individual will be responsible for direct interaction with a number of global regulatory authorities as well as BlueRock business partners and academic collaborators.

Responsibilities:

Seek innovative opportunities and solutions to advance portfolio products by maintaining an awareness of the rapidly changing global regulatory environment

Work with cross-functional teams to develop and deliver new INDs, key IND Amendments, and global marketing applications

Identify potential risks and work with cross-functional teams to identify and implement mitigation strategiesMaintain a long-term view and adapt regulatory strategy as data and regulatory guidance as precedence evolves

Set direction for global regulatory submissions and lead teams that will author supportive documents

Work with CROs on required global submissions to support and conduct of clinical trials

Prepare and deliver effective presentations

Provide leadership on cross functional teams and subcommittees

Maintain a global view and awareness as programs advance

Develop core departmental structure and critical processes to support growth

Minimum Requirements:

Minimum of a Bachelor’s degree is required.

PhD or Masters in a scientific discipline is preferred.

Minimum of 5 years of global regulatory experience for a life sciences company is required.

International regulatory experience is a plus.

Direct preclinical and clinical regulatory strategy

Comprehensive knowledge of applicable regulations

Experience in interpretation of regulations, guidelines, and policy statements on a global level

Experience in the preparation of major submissions and supportive amendments or supplements

Solid knowledge of GCPs and GLPs

Minimum of 2 years of direct experience interfacing with regulatory authorities

Ability to lead and influence diverse, cross-functional teams

Demonstrated leadership and communication skills

Ability to represent department with executive management, partners, and collaborators

Experience with cell and gene therapy and/or medical devices are a plus.

Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 20% is required.

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.