Senior Director, Regulatory Labeling, Advertising and Promotion

Role Summary

The Sr. Director, Regulatory Labeling, Advertising and Promotion is a strategic role leading the review and approval and submission of advertising and promotional materials, related training, and other nonproduct commercial communications. The Sr. Director will also be responsible for developing and managing labeling globally. Will lead the cross functional product labeling team. In this role, you will be responsible for ensuring compliance with regulatory agencies’ requirements and Invivyd’s promotional, medical, and corporate communications objectives. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new and updated regulations and guidance documents for both labeling and promotion.

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 the pharmaceutical/biotech Industry as it pertains to labeling and promotion
• Effectively partner and collaborates with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that 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 are made
• Provide strategic regulatory advice for labeling taking into consideration marketing use post-approval
• Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management
• Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities

Qualifications

• Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)
• Minimum of eight years working in the pharmaceutical or biotech industry with a minimum of 10-15 years in Regulatory Affairs
• Experience working with OPDP
• Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion
• Knowledge of US regulations for labeling
• Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus
• Ability to work in a fast-paced environment where drive is critical to success
• Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions in order to reach resolution
• Strong writing, project management and communication skills
• Ability to travel as needed (likely 1x a month) to our New Haven, CT office