Beam Therapeutics · 1 month ago
Manager Regulatory Affairs
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $155K/yr
8+ years expBeam Therapeutics is a biotechnology company focused on precision genetic medicines. They are seeking a Manager Regulatory Affairs to develop and implement the global regulatory strategy for their advanced genetic medicine portfolio in a dynamic biotech environment.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
In partnership and under guidance from the Regulatory Lead, drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy
Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
Maintain and update regulatory submission plans, timelines, and other core strategic documents
As needed, represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Other activities as needed
Qualification
Required
BS in a medical or scientific field required
Strong grasp of drug development lifecycle and strategy
A minimum of 8 years of experience working in Regulatory Affairs
Knowledge of US and global regulatory procedures and practices
Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
Ability to develop and maintain collaborative working relationships with internal and external partners
Excellent written/verbal communication skills, attention to detail, organizational skills
Preferred
An advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
Additional experience in other fields of the biotech industry is a plus
Experience with advanced therapies a plus
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam 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 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2026-01-13
thefly.com
2026-01-13
Company data provided by crunchbase