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

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.