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.
Position Summary: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.
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
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
- Experience with document management and RIM systems, Veeva Vault (RIM Suite) experience preferred
- 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
Pay Range$120,000 - $160,000The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.
