Invivyd, Inc
Senior Director, Regulatory Labeling, Advertising and Promotion New Haven, CT (N
Invivyd, Inc, New Haven, Connecticut, us, 06540
Senior Director, Regulatory Labeling, Advertising and Promotion
Location: New Haven, CT (Northeast preferred) – hybrid position with both at-home remote work and time at our New Haven HQ.
About Us At Invivyd, Inc., we are driven by the mission to protect people 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 we received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in our pipeline. In October 2025 the FDA cleared our Investigational New Drug (IND) application for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd.
Responsibilities
Represents Regulatory Affairs as a member of the 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 U.S. 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 collaborate 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 manage 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 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 U.S. regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products, particularly related to advertising and promotion.
Knowledge of U.S. 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 once a month) to our New Haven, CT office.
Equal Opportunity Employer At Invivyd we strive to create a welcoming and inclusive environment. 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.
#LI‑DL1
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About Us At Invivyd, Inc., we are driven by the mission to protect people 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 we received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in our pipeline. In October 2025 the FDA cleared our Investigational New Drug (IND) application for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd.
Responsibilities
Represents Regulatory Affairs as a member of the 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 U.S. 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 collaborate 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 manage 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 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 U.S. regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products, particularly related to advertising and promotion.
Knowledge of U.S. 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 once a month) to our New Haven, CT office.
Equal Opportunity Employer At Invivyd we strive to create a welcoming and inclusive environment. 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.
#LI‑DL1
#J-18808-Ljbffr