Establish and lead Commercial Regulatory Affairs and Regulatory Labeling functions.
Develop strategy, build teams, and implement systems for compliance with FDA and global health authority requirements.
Provide strategic leadership across Marketing, Medical Affairs, Legal, Clinical, and Commercial teams.
Guide risk-based decisions and enable compliant business growth.
Conduct regulatory intelligence, digital and global promotional oversight, and labeling governance.
Engage with regulatory agencies directly, managing advisory comment requests and submission of promotional materials.

Bachelor’s degree in a scientific discipline; advanced degree (MD, PharmD, PhD) strongly preferred.
Minimum of 15 years of Regulatory leadership roles of increasing responsibility with small and large multi-national biopharma companies. Significant direct experience in advertising, promotion, and labeling required.
Comprehensive knowledge of FDA and global regulations for labeling and promotional compliance.
Experience with global product launches and lifecycle management.
Strong strategic and operational skills; ability to balance short-term needs with long-term vision.
Strong interpersonal and leadership skills to work both independently and collaboratively as part of multidisciplinary teams in a fast-paced, distributed and highly matrixed environment.
Demonstrated experience in building regulatory teams, systems and processes appropriate to scale.
High organizational awareness and ability to connect cross-functional priorities.

Vice President, Regulatory Affairs – Advertising, Promotion, and Labeling

Key skills