Senior Director, Regulatory Affairs

Beam Therapeutics • Cambridge, MA

8d • $260,000 - $320,000 • Hybrid

About The Position

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.

Requirements

• 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.
• Supervisory responsibility over professional-level Regulatory Affairs staff (including Managers, Regulatory Affairs).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director