Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion

The Company is seeking an Executive Director of Regulatory Affairs, Labeling, Advertising & Promotion to lead global labeling and promotional regulatory strategies across development programs and commercial products. The role oversees the creation and maintenance of product labeling and promotional materials, ensures compliance with applicable health authority requirements, and leads agency discussions and negotiations. The executive will guide and mentor regulatory professionals, assess risks, and provide practical solutions to cross-functional teams. They will also partner with commercial, medical, clinical, communications, and legal teams to align materials and messaging with regulatory requirements and business objectives. Candidates must have a bachelor’s degree in a life sciences discipline and at least 15 years of pharmaceutical regulatory affairs experience, including eight or more years focused on labeling and advertising or promotional compliance. Required qualifications include experience leading regulatory teams and working with senior executives, expert knowledge of FDA regulations and guidance, and strong writing, negotiation, and public-speaking skills. An advanced degree and experience with international labeling requirements are preferred.