Position Overview

• 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

Professional Experience and Requirements

• 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

 Benefits

• PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.