Senior Director, Regulatory Labeling, Advertising and Promotion

Role Summary

The Senior Director, Regulatory Labeling, Advertising and Promotion leads the strategic review, approval, and submission of advertising and promotional materials, related training, and other nonproduct communications. Responsible for global labeling development and management, leading the cross-functional product labeling team, and ensuring compliance with regulatory requirements and corporate communications objectives. Monitors regulatory compliance trends and interprets new regulations for labeling and promotion. Coordinates training on advertising, promotion, and product launches, working with Medical Affairs, Legal, Compliance, and Commercial teams.

Responsibilities

• Represents Regulatory Affairs as a member of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials
• Maintain a deep and current awareness of evolving US and global regulations, codes and guidelines, enforcement actions, and policy issues affecting labeling and promotion
• Collaborate with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders to ensure promotional and non-promotional materials are reviewed in a timely fashion throughout the product life cycle
• Primary liaison with OPDP and effectively manages relationships with FDA contacts
• Lead the labeling process, including CCDS, and support systems for new or changes to existing commercial labels
• Provide strategic regulatory advice for labeling considering post-approval marketing use
• Interpret and communicate regulatory perspectives on promotional and non-promotional activities and risks to stakeholders and management
• Coordinate regulatory training on issues pertaining to advertising and promotion activities

Requirements

• Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)
• Minimum of eight years in the pharmaceutical or biotech industry with 10‚Äì15 years in Regulatory Affairs
• Experience working with OPDP
• Thorough knowledge of US regulatory requirements for marketing authorization filings related to advertising and promotion
• Knowledge of US regulations for labeling
• Knowledge of global drug/biologic regulations and standards for promotion; EU and international requirements a plus
• Ability to work in a fast-paced environment with strong drive
• Ability to assess regulatory risk and coordinate discussions to influence all business functions
• Strong writing, project management, and communication skills
• Ability to travel as needed (likely 1x a month) to New Haven, CT