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Regulatory

Director/Sr. Director, Regulatory Affairs

  • Cambridge, MA
  • Added
31

Position Overview:

Beam is seeking a Director/Senior Director of Regulatory Affairs to progress a broad portfolio of advanced genetic medicines in a fast paced and dynamic biotech environment.  The person will be responsible for supporting the development and implementation of the global regulatory strategy for Beam’s programs.

Responsibilities:

  • Participate and help drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy
  • Incorporate the evolving global regulatory requirements and guidances with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other expedited regulatory approval pathways from first-in-human to post-marketing application stage
  • Represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies
  • Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
  • Guide and assist on the planning, preparation, writing and submission of regulatory documentation.
  • Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
  • Provide regulatory due diligence as required
  • Supervise and mentor direct reports

Qualifications:

  • BS required, an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
  • A minimum of 4+ years of experience working in Regulatory Affairs; ideally 10 plus years in the biotech industry At least 8 years in regulatory affairs
  • Comprehensive knowledge of US and global regulatory procedures and practices
  • Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
  • Strong strategic thinking and problem-solving skills
  • Record of success with interactions with Regulatory Agencies and Health Authorities
  • Experience in representing programs to internal and external stakeholders
  • Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors
  • Excellent written/verbal communication skills, attention to detail, organizational skills
  • Demonstrated ability to mentor and manage


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