Manager, Regulatory
About The Position
There 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. In October 2025, the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program 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. The Manager, Regulatory will play a pivotal role in supporting overseeing regulatory activities related to Invivyd's initiatives. This role 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
- 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
- Experience with document management and RIM systems
- 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
- advanced degrees preferred
- 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
Benefits
- annual short-term incentive (e.g., bonus or sales incentive)
- annual long-term incentive (e.g., equity)
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
