Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion
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.
Position Overview: The Manager/Senior Manager, Regulatory — Advertising, Labeling, and Promotion (ALP) is responsible for leading U.S. promotional regulatory strategy and supporting ex-U.S. needs across our gene editing portfolio. This role reports to the Director of Regulatory Labeling and serves as a key member of the Promotional Review Committee (PRC/MLR). The position ensures compliant, compelling, and scientifically accurate communications consistent with core labeling and regulatory requirements.
Responsibilities:
- Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling.
- Manage the lifecycle of core and regional labeling documents including updates, reviews, approvals, and submissions.
- Ensure claims are truthful, non-misleading, balanced, and aligned with approved labeling and scientific evidence.
- Prepare and submit FDA Form 2253 filings; maintain records and track OPDP correspondence in conjunction with regulatory operations.
- Ensure alignment with promotional materials with CCDS, USPI/PI, IFU, and patient labeling.
- Monitor FDA OPDP/CBER guidance's, enforcement trends, and evolving U.S. regulations; educate internal teams.
- Support development of SOPs, governance documents, training programs, and inspection readiness activities.
- Advise cross-functional partners on scientific substantiation, evidence gaps, and claims strategy.
- Review digital and social media content for compliance with fair balance, risk proximity, and evolving digital standards.
Qualifications:
- Bachelor’s degree in a scientific discipline required; advanced degree preferred.
- 8+ years (Manager) 10+ years (Senior Manager) experience in Regulatory Advertising & Promotion.
- Strong understanding of FDA promotional regulations (FD&C Act, 21 CFR 202.1, OPDP/OC, CBER/CDER).
- Hands-on PRC/MLR experience and 2253 submission experience required.
- Excellent communication, cross-functional collaboration, and regulatory judgment.
