Senior Director, Regulatory Affairs

Primary Responsibilities:

• Supporting development and implementation of global regulatory strategy for innovative genetic medicine programs within a fast-paced biotechnology environment.
• Ensuring integration of regulatory tactics with broader corporate strategy across non-clinical, clinical and commercial development stages.
• Incorporating evolving United States and global regulatory requirements related to gene editing, gene therapy, rare disease, orphan indications, breakthrough therapies and expedited regulatory pathways.
• Representing the Regulatory Affairs function on cross-functional and project teams to provide regulatory input throughout development.
• Developing innovative regulatory approaches, solutions and guidance while mitigating regulatory risks.
• Collaborating with external stakeholders, including experts, consultants and contracted vendors.
• Guiding planning, preparation, construction and submission of regulatory documentation.
• Managing project plans, timelines and prioritization to ensure milestones and goals are achieved.
• Providing regulatory due diligence support.

Qualifications:

• Bachelor’s Degree or foreign equivalent, in regulatory affairs; or a closely related field plus:
• • Five (5) years of progressive, post-baccalaureate experience including:
    • Working in regulatory affairs
    • Developing regulatory documents and submissions; and
    • Presenting corporate development programs to regulatory agencies.
  • The required five years must also include at least one year of experience (which may have been gained concurrently) involving:
    • Regulatory affairs work within biotechnology specifically, including application of U.S. and global regulatory procedures and practices;
    • Developing regulatory documents and submissions such as IND, CTA/IMPD, BLA, MAA and PIP; and
    • Managing projects in biotechnology regulatory affairs.

Other Information:

• Permanent, full-time, immediately available, job opportunity;
• No travel required
• Hybrid role – some telecommuting permitted, but must work onsite in Beam Therapeutics’ Cambridge, MA office most of the time (at least three days per week);
• 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);
• This is because Beam headquarters at 238 Main Street, Cambridge, MA 02142, this is the primary worksite for the role long-term; and
• Role supports global regulatory strategy for advanced genetic medicines programs; and
• Supervisory responsibility over professional-level Regulatory Affairs staff (including Managers, Regulatory Affairs).