BlueRock Therapeutics Senior Manager, Regulatory Affairs in Cambridge, Massachusetts
Senior Manager, Regulatory Affairs
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.
Description of Position:
The incumbent will be responsible for supporting preparation of regulatory submission documents to support global clinical development, product registration, and post-approval life cycle management. This position will provide regulatory support on projects by working with senior regulatory management to implement regulatory strategy and development plans and oversee regulatory submissions. Individual will also maintain awareness of global regulatory environment for cell therapies including accelerated review programs and the impact on product development programs.
Develop and implement regulatory strategies, including the identification of gaps or risks and opportunities to expedite development through innovative pathways
Facilitate subject matter experts in preparing regulatory submissions including briefing documents, IND/CTA filings, and marketing applications.
Prepare regulatory documents including Module 1, meeting requests, meeting information packages, and Fast Track, Breakthrough, RMAT, PRIME designations.
Oversee all aspects of regulatory submissions (e.g., INDs, CTAs, BLA, etc.) including content development and organization and coordination of cross-functional team activities.
Ensure of compliance with applicable Health Authority requirements.
Establish regulatory direction for programs including regulatory requirements and strategies for non-clinical study plans.
Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs.
Represent the Regulatory Affairs Department as a member of cross-functional project teams and provide guidance relating to changing global regulatory requirements.
Proactively manage critical regulatory issues and work with team members to resolve issues related to non-clinical studies.
Interface with external consultants, study leaders, CROs etc. to provide regulatory guidance related to nonclinical operations and nonclinical development plans.
BS degree in a biological science or related field is required; MS/PhD preferred.
Solid knowledge of FDA, EMA and other global regulations/regulatory requirements and ICH guidelines
Minimum of 8 years of experience in the pharmaceutical or biotechnology industry including at least 3 years of experience within the Regulatory Affairs function.
Experience in cell and gene therapy strongly preferred.
International regulatory experience strongly desired.
Experience in preparing regulatory filings including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with health authorities, leading and managing regulatory teams
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 in development and nonclinical testing of cell and gene therapeutics is highly desirable.
Experience in the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.
Experience in developing briefing documents and interfacing with regulatory agencies to address matters regarding non-clinical testing plans.
Ability to understand technical aspects of nonclinical studies 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 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.