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 guidances, 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.