Director/Sr. Director, Regulatory Labeling, Advertising and Promotion

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Be part of Invivyd. In this role, you will be responsible for ensuring compliance with regulatory agencies’ requirements and Invivyd’s promotional, medical, and corporate communications objectives. 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 Requirements • 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