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

About the Role

We are seeking a Vice President, Regulatory Affairs (Advertising, Promotion, and Labeling) to join our team. The Vice President, Regulatory Affairs will establish and lead two critical functions—Commercial Regulatory Affairs and Regulatory Labeling—for a growing biotech organization. This executive will develop strategy, build teams, and implement systems to ensure compliance with FDA and global health authority requirements for promotional materials and product labeling.

The role provides strategic leadership across Marketing, Medical Affairs, Legal, Clinical, and Commercial teams, guiding risk-based decisions and enabling compliant business growth. Responsibilities include regulatory intelligence, digital and global promotional oversight, labeling governance, and direct engagement with regulatory agencies.

This position reports to the Senior Vice President, Regulatory Affairs and Medical Writing, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

• Build and lead the Commercial Regulatory Affairs function, including policies, processes, and governance for promotional review.

• Serve as internal expert on FDA regulations, guidance, and enforcement trends governing advertising and promotion of prescription drugs.

• Provide strategic and operational leadership to Marketing, Medical Affairs, Legal, and Clinical teams in developing compliant promotional materials aligned with business objectives.

• Conduct detailed review of clinical evidence supporting proposed claims; ensure consistency with FDA-approved labeling.

• Oversee review and approval of promotional materials across all channels (digital, print, social media, training, press releases).

• Serve as primary contact for FDA’s OPDP, managing advisory comment requests, negotiations, and pre-clearance of launch materials.

• Direct timely submission of all approved promotional materials to FDA on Form 2253.

• Monitor regulatory developments and enforcement actions; proactively update stakeholders and guide risk mitigation strategies.

• Establish and lead the Regulatory Labeling function, including governance, processes, and systems for labeling development and maintenance.

• Oversee creation and lifecycle management of prescribing information, patient labeling, and packaging components for all products.

• Ensure labeling compliance with FDA and global health authority requirements; manage updates driven by regulatory changes, safety signals, or new data.

• Partner with Clinical, Medical, and Commercial teams to align labeling strategy with product development and commercialization plans.

• Implement labeling change control processes and ensure timely submission of updated labeling to regulatory authorities.

• Develop labeling standards and templates; ensure consistency across global markets.

• Represent labeling function in cross-functional teams and regulatory interactions.

• Recruit, develop, and mentor regulatory professionals; build high-performing teams for both functions.

• Drive a culture of excellence, innovation, and accountability; reward initiative and performance.

• Establish KPIs for regulatory review and labeling processes; lead continuous improvement initiatives.

• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans

• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies

• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices

• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any

• Some international travel may be required

• Other duties as assigned

• Bachelor’s degree in a scientific discipline; advanced degree (MD,…