Executive Director, Head of Regulatory Affairs
pmvpharma
- Princeton, NJ
- Permanent
- Full-time
Job Description: Executive Director, Head of Regulatory Affairs
Reports to: Chief Development Officer
Location: Hybrid (2 days a week in Princeton, NJ office)Position Overview The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives. The candidate will be responsible for working with global health authorities to appropriately position PMV’s innovative products while also ensuring efficient and compliant internal regulatory operations.
This leader will be responsible for developing regulatory strategies, overseeing the filing of applications, leading and positively impacting global Health Authority interactions, and managing the team associated with these activities.Primary Responsibilities
- Leads global strategic and operational planning, management, support and execution of regulatory activities
- Builds and manages strong relationships with cross-functional internal colleagues, as well as between the regulatory team and regulatory agencies, external CROs, regulatory consulting groups, and other third parties.
- Defines strategies for, coordinates the execution of regulatory submissions including, but not limited to: Investigational New Drug applications, New Drug Applications and equivalent international filings
- Advises project teams and collaborates cross-functionally with clinical, preclinical, pharmaceutical development, commercial and external resources on Regulatory Affairs issues to promote global acceptability of programs
- Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving interactions and overseeing Health Authority meeting preparation throughout the organization
- Champions new ways of meeting targets and/or goals, risk mitigation strategies, facilitates the rapid transfer of best practices and explores critical issues not explicitly addressed by others
- Develops and maintains responsive, motivated and efficient teams to ensure results orientation and continuous improvement
- Develops policies and procedures, as needed
- Manages, coaches, and mentors direct reports
- Bachelor’s degree in a scientific discipline is required, advanced degree is a plus
- Minimum of 10 years of progressively increasing experience in a pharmaceutical or biotechnology organization including significant experience in a Regulatory Affairs leadership role
- Oncology experience required
- Regulatory CMC and CDx experience is preferred
- In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EU
- Proven record of success in gaining regulatory approval through relationship building with global health authorities; experience with INDs, NDAs, CTAs, and post-marketing/life cycle management (e.g. variations, renewals, labeling)
- Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related aspects and their intersection with Regulatory Affairs
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports and building or growing a regulatory affairs function
- Excellent verbal and written communication skills
- Successful management of projects to completion meeting budgets and timelines
- PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.