Join to apply for the Senior Director, Regulatory Labeling, Advertising and Promotion role at Invivyd The Senior 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. In this role, you will be responsible for ensuring compliance with regulatory agencies’ requirements and Invivyd’s promotional, medical, and corporate communications objectives. The Senior Director, Regulatory Labeling, Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch 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
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