Senior Director, Regulatory Affairs

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

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).

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range
$260,000—$320,000 USD