BlueRock Therapeutics is a next-generation regenerative medicine company focused on breakthrough treatments and new horizons in medicine. BlueRock Therapeutics platform is based on state of the art pluripotent stem cell engineering tools and expansion technology. The company represents a strategic partnership between Bayer and Versant Ventures, and has been granted access to one of the largest-ever Series A financings in biotech.
Our vision at BlueRock is to cure cardiovascular, neurologic and other diseases with significant unmet need and diminished self-repair potential. Our platform is enabled by strategic partnerships with leading academic and industry collaborators in the U.S., Canada and Japan.
BlueRock`s ambition is to create a Regulatory Sciences team staffed with top scientists and developers who are inspired to take project ownership and establish themselves as a leader in one of the most rapidly growing translational fields. At BlueRock we value open communication, collaboration and a positive and fun working environment in which both individual and team contributions are recognized. Our world-class management team is committed to fostering the growth and career development of employees.
The Cambridge, MA site has an outstanding opportunity for an accomplished Regulatory Affairs professional to contribute to bringing a new class of medicines to patients while gaining valuable career experience in translational medicine
The incumbent will be responsible for leading preparation of regulatory submissions to support global clinical development, product registration, and post-approval life cycle management. This position will provide overall leadership and regulatory direction on projects by working with internal program teams to develop regulatory strategy and development plans and will interface with external consultants and regulatory agencies in developing regulatory submissions. Individual will also maintain awareness of global regulatory environment for cell therapies including accelerated review programs and assess and communicate impact of changes in regulatory policies on business and product development programs.
Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA filings, and marketing applications. Oversee preparation of responses to all regulatory authority queries.
Establish regulatory direction for programs including CMC strategy, non-clinical study plans, regulatory requirements for clinical studies and marketing approval in domestic and international markets, and regulatory strategic development plans.
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.
Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs. Assess the impact of changes on business and product development programs and communicate to the BlueRock development teams and management.
Proactively manage critical regulatory issues and work with team members to resolve issues related to Quality, CMC, non-clinical studies, and clinical development.
Interface with external consultants, clinicians, CROs etc. to provide regulatory guidance related to clinical operations and clinical development plans.
BS degree in a biological science or related field is required; MS/PhD preferred.
A minimum of 10 years experience in the pharmaceutical or biotechnology industry including five years of leadership experience within the Regulatory Affairs function.
Extensive 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
Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation
Knowledge and understanding of US and international regulations and ICH guidelines related to biologics and cell therapy development
Experience in development, manufacturing and testing of cell therapeutics is highly desirable.
Experience in regulatory filing for medical devices or combination products, such as cell therapy and delivery device, is highly desirable.
Experience in leading 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 and CMC strategy.
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.
BlueRock Therapeutics is an equal opportunity employer and supports workforce diversity. BlueRock welcomes and encourages applications from people with disabilities. Accommodations are available by request for candidates taking part in all aspects of the selection process.