Director, Regulatory Affairs Global Clinical 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.
This position reports to Vice President, Regulatory Affairs and Medical Writing. The incumbent will be responsible for developing the regulatory strategy and managing the preparation and submission of documents to support global clinical development in the neurology therapeutic area. This role involves working closely with clinical, nonclinical, and CMC teams and is responsible for driving regulatory strategies to advance the BlueRock portfolio. This position will serve as point of contact for interactions with global health authorities to achieve alignment on project-specific regulatory submission activities. This individual will also maintain awareness of global regulatory environment for cell therapies including accelerated development opportunities with the potential to accelerate assigned programs. Responsibilities

Serves as the global regulatory strategy lead developing and managing global regulatory programs for complex advanced cell therapies from preclinical stages through marketing authorization

Leads the global regulatory strategy subteam to effectively and collaboratively design and execute a global regulatory strategies across nonclinical, CMC, clinical, device, medical writing, and program management disciplines in alignment with the overall program development plans and corporate goals.

Act as the primary interface with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and expediting approvals of product.

Leads the planning, strategy, content and execution of submissions inclusive of Health Authority interactions, IND/CTAs, BLA/MAA filings, and designations throughout lifecycle management.

Serves on Core Program Team to openly and effectively communicate regulatory strategies and works with cross-functional disciplines to collaboratively identify opportunities and propose solutions to advance programs

Assist in planning, writing, and reviewing regulatory document submissions

Interface with external consultants, study leaders, CROs etc. to provide regulatory guidance and managerial support related to clinical development

Work collaboratively with other regulatory colleagues, externally or internally based, to ensure regulatory milestones are achieved across projects and across regulatory disciplines

Support departmental initiatives, including special projects, budgeting, and authoring departmental documents

Maintain detailed knowledge of global regulatory environment relevant for cell and gene therapies and regenerative medicine including accelerated review programs

Identify gaps or risks and opportunities to expedite development through innovative pathways

Requirements

MS, PharmD, or PhD in a biological science or related field is preferred; bachelor’s degree required

Minimum of 8-10 years of experience in pharmaceutical/biotechnology drug development as a regulatory lead ideally with US and EU filings; global late-stage clinical regulatory experience with biologic drug products, cell or gene therapy is desired

Experience in the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments; experience in global late phase clinical development strongly desired

Experience in preparing global regulatory filings and interactions with global regulatory authorities

Solid knowledge of US, EU, and other global regulations/regulatory requirements and ICH guidelines; knowledge of MHRA, China, and Japanese regulatory environment a strong plus

Knowledge of radioimaging, biomarker strategy, and digital health technologies a strong plus

Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of agencies and ensuring compliance with regulations in all regions

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

Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced environment.

Excellent written and communication skills with attention to detail; highly computer literate (Word, Excel PowerPoint, SharePoint), including formatting documents for regulatory submission; experience with Veeva preferred

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 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.