BlueRock Therapeutics · 2 days ago
Director, Regulatory Affairs Strategy
Cambridge, MA
Full-time
Onsite
Director/Executive
$200K/yr - $230K/yr
8+ years expBlueRock Therapeutics is a clinical stage cell therapy company focused on developing innovative treatments for neurological and ophthalmic diseases. They are seeking a Director of Regulatory Affairs Strategy to lead global regulatory activities, shape regulatory strategy, and ensure compliance throughout the development lifecycle of their cell therapy programs.
BiopharmaBiotechnologyHealth CareMedical
Responsibilities
Develop overall regulatory strategy for assigned programs, working closely with the nonclinical and clinical teams, in conjunction with the Regulatory CMC and Device leads
Provide 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 SMEs
Provide 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 pathways
Collaborate 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 stakeholders
Contribute to regulatory department initiatives to develop procedures and working practices
Qualification
Required
Strong knowledge of US and international regulations and ICH guidelines
BS or MS degree in a scientific discipline or related field is required
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
Experience preparing documents for regulatory filings including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with health authorities
Experience developing and implementing complex regulatory strategies
Experience developing briefing documents and interfacing with regulatory agencies
Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box
Ability to set priorities, work independently, deliver results in a timely manner and adapt and react to new information or changing priorities
Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences
Excellent 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
Preferred
MS/PhD preferred
International regulatory experience a plus
Company
BlueRock Therapeutics
It is a regenerative medicine company.
201-500 employees
H1B Sponsorship
BlueRock Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (5)
2022 (3)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$225M2019-08-08Acquired
2016-12-12Series A· $225M
Leadership Team
Seth Ettenberg
President and CEO
Stefan Irion
Chief Scientific Officer
Recent News
2025-12-02
Company data provided by crunchbase