Manager, Regulatory

Invivyd•New Haven, CT

5h•Hybrid

About The Position

Invivyd, Inc. is dedicated to protecting immunocompromised individuals from serious viral infectious diseases, starting with SARS-CoV-2. The company utilizes a proprietary integrated technology platform to develop and adapt best-in-class antibodies. Invivyd received emergency use authorization (EUA) from the U.S. FDA in March 2024 for a monoclonal antibody and had its Investigational New Drug (IND) application cleared by the FDA in October 2025 for VYD2311, a vaccine alternative monoclonal antibody for COVID-19 prevention. The Manager, Regulatory will play a pivotal role in supporting and overseeing regulatory activities related to Invivyd's initiatives. This hybrid position involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, organization of regulatory communications and submissions, and collaboration with regional regulatory authorities. While providing valuable support to higher-level management, the Manager, Regulatory focuses on executing regulatory tasks, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for Invivyd’s initiatives.

Requirements

BA/BS degree in biological/physical sciences required, advanced degrees preferred
5+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience
Strong understanding of the drug development process, pharmaceutical regulatory requirements, healthcare environment and policy
Strong written and oral communication and organizational skills, including ability to prioritize work tasks across multiple projects and timelines
Ability to comprehend complex scientific information and regulatory guidelines, and formulate recommendations based on assessment
Demonstrated ability to effectively work independently (with limited oversight) and/or collaboratively with pragmatism while navigating stressful situations and diverse stakeholders
Experience effectively leading regulatory submissions and interactions in a fast-paced, matrixed environment
Proficient with MS Office tools to perform project management, tracking, writing and presentation tasks
Strong problem-solving skills and attention to detail
Must have the ability to present a positive and professional image through communication and interaction with key stakeholders, including colleagues, customers, vendors, and appropriate regulatory authorities, with the adeptness to work autonomously and effectively manage time to deliver results within defined timelines
Ability to work onsite at least 1x/week in New Haven HQ

Nice To Haves

Veeva Vault (RIM Suite) experience preferred

Responsibilities

Accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)BLA, MAA, variations, etc. in compliance with applicable regulatory requirements
Lead the compilation of Agency interaction documents such as Meeting Requests and Meeting Packages
Lead Labeling Working Group for assigned submissions and responsible for USPI annotations and mockups
In alignment with the global regulatory team, assist with management of regulatory activities related to assigned projects that encompass technical areas including clinical, non-clinical, and CMC
Organizes and maintains regulatory files within the regulatory information management (RIM) system to ensure the Company’s compliance with regulatory requirements
May guide one or more associates or contractors to handle regional requests and associated documentation