Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion Job at Beam Therapeutics (Cambridge)

Job Description

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.

Job Responsibility

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

Requirements

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

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Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion

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