Senior Manager

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 that includes a suite of gene editing and delivery technologies and is in the process of building 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 potential 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.

Position Overview:

Beam is seeking a Senior Manager 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 non-malignant hematology programs.

Responsibilities:

• In partnership and under guidance from the Regulatory Lead, 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 evolving global regulatory requirements and guidances with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
• Maintain and update regulatory submission plans, timelines, and other core strategic documents
• As needed, represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies
• 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
• Other activities as needed

Qualifications:

• BS in a medical or scientific field required, an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
• Strong grasp of drug development lifecycle and strategy; experience with gene therapy highly preferred
• 10 years experience in biotech/pharma, a minimum of 5 years of which working in Regulatory Affairs
• Knowledge of US and global regulatory procedures and practices; previous interactions with health authorities is a plus
• Experience with Veeva RIM, smartsheet, and/or MS Project is a plus
• Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
• Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
• Ability to develop and maintain collaborative working relationships with internal and external partners
• Excellent written/verbal communication skills, attention to detail, organizational skills
• Onsite requirements: candidates are expected to come onsite 1-3 days per week.