PMV Pharmaceuticals, Inc
Executive Director, Head of Regulatory Affairs
PMV Pharmaceuticals, Inc, Princeton, New Jersey, us, 08543
Executive Director, Head of Regulatory Affairs
Reports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)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 activitiesBuilds 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 filingsAdvises project teams and collaborates cross-functionally with clinical, preclinical, pharmaceutical development, commercial and external resources on Regulatory Affairs issues to promote global acceptability of programsServes as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving interactions and overseeing Health Authority meeting preparation throughout the organizationChampions 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 othersDevelops and maintains responsive, motivated and efficient teams to ensure results orientation and continuous improvementDevelops policies and procedures, as neededManages, coaches, and mentors direct reportsProfessional Experience and Requirements
Bachelor’s degree in a scientific discipline is required, advanced degree is a plusMinimum of 10 years of progressively increasing experience in a pharmaceutical or biotechnology organization including significant experience in a Regulatory Affairs leadership roleOncology experience requiredRegulatory CMC and CDx experience is preferredIn-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EUProven 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 AffairsDemonstrated leadership ability and experience managing, coaching and mentoring direct reports and building or growing a regulatory affairs functionExcellent verbal and written communication skillsSuccessful management of projects to completion meeting budgets and timelinesPMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
#J-18808-Ljbffr
Reports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)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 activitiesBuilds 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 filingsAdvises project teams and collaborates cross-functionally with clinical, preclinical, pharmaceutical development, commercial and external resources on Regulatory Affairs issues to promote global acceptability of programsServes as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving interactions and overseeing Health Authority meeting preparation throughout the organizationChampions 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 othersDevelops and maintains responsive, motivated and efficient teams to ensure results orientation and continuous improvementDevelops policies and procedures, as neededManages, coaches, and mentors direct reportsProfessional Experience and Requirements
Bachelor’s degree in a scientific discipline is required, advanced degree is a plusMinimum of 10 years of progressively increasing experience in a pharmaceutical or biotechnology organization including significant experience in a Regulatory Affairs leadership roleOncology experience requiredRegulatory CMC and CDx experience is preferredIn-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EUProven 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 AffairsDemonstrated leadership ability and experience managing, coaching and mentoring direct reports and building or growing a regulatory affairs functionExcellent verbal and written communication skillsSuccessful management of projects to completion meeting budgets and timelinesPMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
#J-18808-Ljbffr