Description

Opening for role of Senior Director, Regulatory Affiars, with and at Beam Therapeutics, Inc. (“Beam” or “Beam Therapeutics”), headquartered at 238 Main Street, Cambridge, MA 02142.  This would also be the primary worksite for the role long-term.  This is a permanent, immediately available, job opportunity that does not require travel (as role is substantially laboratory-based, in-house).  Must live in the City of Cambridge, MA, or within a reasonable, daily commuting distance thereof (e.g., areas contemplated can include the City of Boston, the larger Greater Boston region, or Massachusetts’ MetroWest, North or South Shore communities).  Note that telecommuting (exclusively working remotely from home) is not permitted (also due to the laboratory-based nature of the work and role).  Job description follows.

This role supports development and implementation of global regulatory strategy for innovative Beam programs, aimed at progressing a broad portfolio of advanced genetic medicines, developed in a fast-paced and dynamic, biotechnology environment. It ensures integration of regulatory tactics supporting broader corporate strategy; and incorporates evolving global regulatory requirements and guidance in areas that span gene editing, gene therapy, rare disease, orphan indications, breakthrough treatments, and other expedited regulatory approval pathways, from first-in-human to post-marketing application stages. Position represents the Regulatory Affairs function on cross-functional and project teams at Beam in the interest of ensuring regulatory input in non-clinical, clinical and commercial stages of development. It develops and provides innovative regulatory approaches, solutions and guidance to cross-functional teams of Beam, all the while mitigating regulatory risks to the company. It collaborates influentially with external stakeholders that include experts, consultants and contracted vendors. Role will guide planning, preparation, construction and submission of regulatory documentation. It manages project plans and timelines to ensure appropriate project prioritization, and that milestones and goals are met on time. Role, finally, provides regulatory due diligence and supervises direct reports occupying professional positions of Manager, Regulatory Affairs.

Full-time position; base annual salary ranging from $225,000.00 to $250,000.00 per year.  It requires a Bachelor’s Degree in regulatory affairs or related field. It also requires five years of the following, progressive, post-baccalaureate experience: (a) working in the regulatory affairs space; (b) hands-on developing regulatory documents and submissions; and (c) presenting corporate development programs to regulatory agencies. Note, too, that this broader, “umbrella” requirement of five years of required experience, it must also include one year (which may have been gained concurrently), so invested as follows: (i) working in the regulatory affairs field but for biotechnology specifically, and also applying knowledge of both United States and global regulatory procedures and practices; (ii) developing regulatory documents and submissions spanning specific settings that include IND, CTA/IMPD, BLA, MAA and PIP; and (iii) managing projects in biotechnology regulatory affairs specifically. 

Applicants should send resumes directly to the employer, not the local state employment-service office.  May specifically apply directly to job posting for the role found on the “Careers” page to our website at https://beamtx.com/careers/.  All submissions will be promptly reviewed.