Senior Vice President/Vice President, Regulatory AffairsHybrid/Northeast
ABOUT US At Invivyd, Inc., we are dedicated to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB platform combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, facilitating the rapid generation of new monoclonal antibodies (mAbs).
We invite you to join our team of innovators and disrupters who are passionate about saving lives and embracing change as a catalyst for new opportunities.
This is your chance to be part of the company with the first mAb authorized in over a year for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents.
Invivyd has an exciting opportunity for a Senior Vice President of Regulatory Affairs and Quality Assurance. This leader will drive all facets of Invivyd's regulatory and clinical quality assurance functions, including regulatory strategy, client interactions, global regulatory submissions, and collaboration with CMC, Quality, and Clinical teams.
Responsibilities: Provide strategic and operational regulatory leadership and mentorship on projects, including regulatory strategies and requirements for clinical studies and marketing approvals.Lead and provide strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments.Develop and maintain a high-performing regulatory team.Plan and implement meetings with regulatory authorities and effectively represent Invivyd.Interpret complex scientific issues related to regulatory requirements and strategy.Identify regulatory issues and offer creative solutions and strategies.Communicate compliance obligations under laws, regulations, and guidance globally.Direct and negotiate submissions (IND, CTA, BLA, MAA) with regulatory authorities.Lead the development and submission of documents to regulatory agencies.Support regulatory reviews for due diligence initiatives.Monitor global regulatory guidelines and anticipate trends affecting the regulatory environment.Oversee the design, analysis, and oversight of global clinical Quality Management System (QMS) policies and procedures.Oversee quality assurance of GCP, GVP, and GLP activities to ensure patient safety and data integrity.Requirements: BS/MS required; PhD or MD preferred.15+ years' experience in Regulatory Affairs and Quality Assurance with 10+ years in leadership roles.Experience leading regulatory filings for biologics, with significant BLA/MAA experience.Successful negotiations and regulatory filings experience with CDER.Experience with COVID-19 therapeutics or monoclonal antibodies is essential.Additional infectious disease experience is a plus.Ability to work cross-functionally and collaboratively is necessary.Candidates located in the Northeast are preferred.At Invivyd, we strive to create a welcoming and inclusive environment. We provide equal consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics. Invivyd is proud to be an equal opportunity employer.
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