Director, Regulatory Labeling

Company Overview:

Beam Therapeutics is a clinical stage 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 has used to advance a diversified portfolio of base editing programs, including four programs to the clinic. Beam’s lead program, BEAM-101 has recently demonstrated clinical validation in Sickle cell disease through upregulation of fetal hemoglobin in patients. 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 Director of Regulatory Affairs – Advertising, Labeling, and Promotion to progress advanced genetic medicines in a fast paced and dynamic biotech environment. The person will be responsible for leading all regulatory labeling activities for Beam’s hematology programs including creation of documents (e.g. CDS, USPI) and processes

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Responsibilitie

• s:Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profile
• s.Lead labeling negotiations between Beam and health authorities as part of marketing authorization application
• s.Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentatio
• n.Represent Regulatory Affairs as part of the Promotional Review Proces
• s.Incorporate the evolving global regulatory requirements and guidances with respect to gene editing and gene therapy, rare disease, and prescription drug labelin
• g.Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risk
• s.Guide and assist on the planning, preparation, writing and submission of regulatory documentatio
• n.Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on tim
• e.Provide regulatory due diligence as require
• d.Supervise and mentor direct report

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Qualificatio

• ns:BS required, an advanced degree (i.e. MS, PharmD, PhD, MD) is a pl
• us.A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion; ideally 15 plus years in the biotech industry with at least 8 years in regulatory affai
• rs.Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updat
• es.Comprehensive knowledge of US and global regulatory procedures and practic
• es.Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PI
• P).Strong strategic thinking and problem-solving skil
• ls.Experience in representing programs to internal and external stakeholde
• rs.Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendo
• rs.Excellent written/verbal communication skills, attention to detail, organizational skil
• ls.Demonstrated ability to mentor and mana