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

United States, Cambridge 130000.00 - 190000.00 USD / Year · Job Posted February 14, 2026
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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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