Beam Therapeutics · 14 hours ago
Director, Regulatory Labeling
Cambridge, MA
Full-time
Onsite
Director/Executive
$210K/yr - $260K/yr
6+ years expBeam Therapeutics is a biotechnology company focused on precision genetic medicines. They are seeking a Director of Regulatory Affairs to lead regulatory labeling activities for their hematology programs, including the creation of critical regulatory documents and managing negotiations with health authorities.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
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
Provide regulatory due diligence as required
Supervise and mentor direct reports
Qualification
Required
BS required
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors
Excellent written/verbal communication skills, attention to detail, organizational skills
Demonstrated ability to mentor and manage
Preferred
An advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
Ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
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 (9)
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
2025-12-16
2025-12-09
Company data provided by crunchbase