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

Director/Sr. Director, Regulatory Labeling, Advertising and PromotionThere are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.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. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.Be part of making a difference. Be part of Invivyd.Location: New Haven, CT (Northeast preferred)This will be a hybrid position, with both at-home, remote working and time in our New Haven, CT HQ.The Director/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/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.The Director/Sr. Director, Regulatory Labeling, Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch activities. The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for Invivyd's product portfolio.The ideal candidate is someone who thrives in a fast-paced environment, is a strategic problem solver, and is proactive, flexible, detail-oriented, and hands-on.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 materialsMaintain 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 promotionEffectively 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 cyclePrimary Liaison with OPDP and effectively manages relationships with FDA contactsLead the labeling process, including CCDS, and support systems for new or changes to existing commercial labels are madeProvide strategic regulatory advice for labeling taking into consideration marketing use post-approvalInterpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and managementCoordinate regulatory training on regulatory issues pertaining to advertisement and promotion activitiesRequirements: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 AffairsExperience working with OPDPThorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotionKnowledge of US regulations for labelingKnowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plusAbility to work in a fast-paced environment where drive is critical to successAbility to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions in order to reach resolutionStrong writing, project management and communication skillsAbility to travel as needed (likely 1x a month) to our New Haven, CT officeAt Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Invivyd is proud to be an equal opportunity employer. We do not accept unsolicited resumes from agencies.