Senior Director, Regulatory Affairs
American Society for Biochemistry and Molecular Biology (ASBMB), Cambridge, MA, United States
Senior Director, Regulatory Affairs
Beam Therapeutics, Inc. (“Beam”) is headquartered at 238 Main Street, Cambridge, MA 02142. This permanent, full‑time position is based at the Cambridge laboratory and requires in‑person work. Candidates must live in Cambridge, MA or a reasonable commuting distance (e.g., Boston, Greater Boston or Mass. MetroWest, North or South Shore). Telecommuting is not permitted.
Responsibilities
Develop and implement the global regulatory strategy for advanced genetic medicine programs.
Integrate regulatory tactics with corporate strategy across gene editing, gene therapy, rare disease, orphan indications, breakthrough treatments, and other expedited pathways.
Guide planning, preparation, construction, and submission of regulatory documentation from first‑in‑human to post‑marketing application stages.
Manage project plans, timelines, priorities, and milestones to ensure on‑time delivery.
Provide regulatory due diligence and supervise direct reports in Manager, Regulatory Affairs roles.
Collaborate with external stakeholders—experts, consultants, and vendors—to facilitate regulatory progress.
Qualifications
Bachelor's degree in regulatory affairs or a related field.
At least five years of progressive, post‑baccalaureate experience in regulatory affairs, including at least one year working in biotechnology and with U.S. and global regulatory procedures.
Experience developing regulatory documents and submissions for IND, CTA/IMPD, BLA, MAA, and PIP.
Demonstrated project management experience in biotechnology regulatory affairs.
Compensation
Annual base salary of $225,000 – $250,000.
Application
Submit your resume directly to Beam via the Careers page at https://beamtx.com/careers/.
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Responsibilities
Develop and implement the global regulatory strategy for advanced genetic medicine programs.
Integrate regulatory tactics with corporate strategy across gene editing, gene therapy, rare disease, orphan indications, breakthrough treatments, and other expedited pathways.
Guide planning, preparation, construction, and submission of regulatory documentation from first‑in‑human to post‑marketing application stages.
Manage project plans, timelines, priorities, and milestones to ensure on‑time delivery.
Provide regulatory due diligence and supervise direct reports in Manager, Regulatory Affairs roles.
Collaborate with external stakeholders—experts, consultants, and vendors—to facilitate regulatory progress.
Qualifications
Bachelor's degree in regulatory affairs or a related field.
At least five years of progressive, post‑baccalaureate experience in regulatory affairs, including at least one year working in biotechnology and with U.S. and global regulatory procedures.
Experience developing regulatory documents and submissions for IND, CTA/IMPD, BLA, MAA, and PIP.
Demonstrated project management experience in biotechnology regulatory affairs.
Compensation
Annual base salary of $225,000 – $250,000.
Application
Submit your resume directly to Beam via the Careers page at https://beamtx.com/careers/.
#J-18808-Ljbffr