Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion
Beam Therapeutics
Job Type
Description
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.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
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About Beam Therapeutics
Beam Therapeutics is a biotechnology company pioneering the use of CRISPR base editing to develop a broad portfolio of advanced genetic medicines.