Who is BlueRock?
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
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 an experienced and strategic Director, Regulatory Affairs Strategy to lead global regulatory activities for our cell therapy programs as the Global Regulatory Lead on assigned program(s). The successful candidate will play a critical role in shaping regulatory strategy, leading health authority interactions, and supporting the preparation and submission of regulatory documentation across the development lifecycle. This is a highly cross-functional role requiring collaboration with Clinical, CMC, Nonclinical, Quality, and Program Management teams to ensure alignment of regulatory strategy with corporate objectives. This position is responsible for the development and implementation of global regulatory strategy on assigned programs, working closely with the nonclinical and clinical teams, and may represent the Regulatory Affairs function on various subcommittees. This individual will guide and/or lead the generation of dossiers in conjunction with Regulatory CMC and Device colleagues to support Health Authority meetings, clinical trial applications and market applications in the US and ex-US territories. Expertise and knowledge of global regulations and guidance for the development of advanced therapies is required.