Director, Regulatory Affairs Strategy

Director, Regulatory Affairs StrategyBlueRock 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.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.Responsibilities:Develop overall regulatory strategy for assigned programs, working closely with the nonclinical and clinical teams, in conjunction with the Regulatory CMC and Device leadsProvide regulatory leadership as the Global Regulatory Lead to program teams and subteams as the go to point of contact for regulatory strategy on assigned program(s)Lead the Regulatory Strategy Subteam(s) in the development of global regulatory plans to support assigned program(s)Collaboratively identify regulatory risks to product development and design risk mitigation strategies as aligned with cross-functional SMEsProvide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathwaysCollaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare regulatory submissions (eg, meeting requests, briefing documents, IND/CTA filings, marketing applications, designation requests, etc)Lead content development, organization, and coordination of cross functional regulatory submissions (e.g., INDs, CTAs, BLA, etc)Author, coordinate, review, and execute submissions and responses to regulatory authorities related to INDs, CTAs, amendments, Information Requests, within appropriate timelines and in accordance with regulations and guidelines.Maintain detailed knowledge of the evolving global regulatory landscape relevant for advanced therapies including accelerated review programs. Assess the impact of new regulations/guidance on internal programs and communicate relevant changes to internal stakeholdersContribute to regulatory department initiatives to develop procedures and working practicesMinimum Requirements:Strong knowledge of US and international regulations and ICH guidelinesBS or MS degree in a scientific discipline or related field is required; MS/PhD preferred.Minimum of 8 years of experience in Regulatory Affairs, with at least some experience in cell or gene therapy.Demonstrated experience with regulatory products to treat rare diseases and/or unmet medical needs (eg, orphan products, fast track, RMAT, breakthrough therapies, PRIME).Demonstrated experience with INDs/ CTAs and life cycle experience. Some experience in cell or gene therapy required. International regulatory experience a plusExperience preparing documents for regulatory filings including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with health authoritiesExperience developing and implementing complex regulatory strategiesExperience developing briefing documents and interfacing with regulatory agenciesEvidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the boxAbility to set priorities, work independently, deliver results in a timely manner and adapt and react to new information or changing prioritiesStrong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiencesExcellent written and oral 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.