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Senior Vice President/Vice President, Regulatory Affairs

Hybrid/Northeast

ABOUT US

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. Our proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

This is your chance to be part of the company with the first mAb authorized in over a year and the only one currently on the market for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.

Be part of making a difference. Be part of Invivyd.

Invivyd has an exciting opportunity to join the team as our Senior Vice President Regulatory Affairs and Quality Assurance. This critical leader and member of our Executive Leadership Team will drive all facets of Invivyd’s regulatory and clinical quality assurance functions. This includes regulatory strategy, leading interactions with clients and global regulatory submissions, representing Invivyd in front of the FDA, EMA, and other regulatory authorities, ensuring close collaboration with CMC, Quality and Clinical teams, as well as external consultants and collaborators, as needed.

Responsibilities:

  • Provides high level strategic and operational regulatory leadership and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and potentially international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Regulatory Agency Interactions
  • You will provide regulatory leadership and provide strategic direction to Regulatory Affairs, Clinical Quality, Medical Writing departments and lead Regulatory Affairs group, including hiring, mentoring, and leading staff
  • Maintain, manage, and develop a high performing regulatory team
  • Drive the planning and implementation of meetings with regulatory authorities and effectively represent Invivyd with regulatory interactions
  • Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provide knowledge and expertise to guide the team in appropriate regulatory strategy
  • Proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation
  • Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world
  • Direct and negotiate submissions (IND, CTA, BLA, MAA etc..) and approvals with regulatory authorities
  • Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory–compliant
  • Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment
  • Monitor global regulatory guidelines and anticipate trends that may impact the regulatory environment to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
  • Oversee the design, analysis, and oversight of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU
  • Oversee the quality oversight of GCP, GVP and GLP activities (including  SOP/policy  development  and maintenance, Vendor Management, internal and external audit functions, and clinical batch release program) 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 leadership experience
  • Experience leading, designing, writing, and submitting regulatory filings for biologics, with significant BLA/MAA experience
  • Track record of successful negotiations and regulatory filings, specifically with the Center for Drug Evaluation and Research (CDER)
  • Experience with COVID-19 therapeutics or monoclonal antibodies is a must
  • Additional infectious disease experience a plus
  • Ability to work cross functionally and collaboratively is a must
  • Candidates located in the Northeast are preferred

At Invivyd we strive to create a welcoming and inclusive environment. Here 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. 

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