Top Regulatory Affairs Executive jobs in New Jersey

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)

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Executive Director, Head of Regulatory Affairs
  • pmvpharma
  • Princeton, NJ FULL_TIME
  • PMV Pharmaceuticals Inc.
    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

    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.

  • 1 Month Ago

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Executive Director, Head of Regulatory Affairs
  • PMV Pharmaceuticals
  • Princeton, NJ FULL_TIME
  • Reports to: Chief Development Officer Location: Hybrid (2 days a week in Princeton, NJ office) The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leaders...
  • 1 Month Ago

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Regulatory Affairs Coordinator
  • QuidelOrtho
  • Raritan, NJ FULL_TIME
  • The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay ...
  • 20 Days Ago

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Senior Regulatory Affairs Associate
  • Breckenridge Pharmaceutical Inc
  • Berkeley Heights, NJ FULL_TIME
  • Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and throu...
  • 21 Days Ago

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Senior Director, Regulatory Affairs
  • SUN_PHARMA
  • NJ, NJ FULL_TIME
  • COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug C...
  • 22 Days Ago

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Regulatory Affairs Specialist – Pharma
  • brenntag
  • Iselin, NJ FULL_TIME
  • Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.Completion of technical and regulatory information requests from custom...
  • 22 Days Ago

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Regulatory Affairs Expert
  • ProKatchers
  • St. Louis, MO
  • Job Description: · With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory t...
  • 4/27/2024 12:00:00 AM

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Regulatory Affairs Expert
  • Integrated Resources Inc ( Iri )
  • Saint Louis, MO
  • Job Title: Regulatory Affairs Expert Job Location: St. Louis, MO- Hybrid Job Duration: 12 Months- Temp to perm possibili...
  • 4/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Prokatchers Llc
  • Saint Louis, MO
  • Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
  • 4/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Gforce Life Sciences
  • Lake Forest, IL
  • Regulatory Affairs Specialist Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medica...
  • 4/27/2024 12:00:00 AM

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Regulatory Affairs Expert
  • Prokatchers
  • Saint Louis, MO
  • Job Description: With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tas...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Lake Forest, IL
  • Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ProKatchers LLC
  • St Louis, MO
  • Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
  • 4/25/2024 12:00:00 AM

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Regulatory Affairs Expert
  • Integrated Resources, Inc ( IRI )
  • St Louis, MO
  • Job Title: Regulatory Affairs Expert Job Location: St. Louis, MO- Hybrid Job Duration: 12 Months- Temp to perm possibili...
  • 4/25/2024 12:00:00 AM

New Jersey is bordered on the north and northeast by New York (parts of which are across the Hudson River, Upper New York Bay, the Kill Van Kull, Newark Bay, and the Arthur Kill); on the east by the Atlantic Ocean; on the southwest by Delaware across Delaware Bay; and on the west by Pennsylvania across the Delaware River. New Jersey is often broadly divided into three geographic regions: North Jersey, Central Jersey, and South Jersey. Some New Jersey residents do not consider Central Jersey a region in its own right, but others believe it is a separate geographic and cultural area from the Nor...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$321,039 to $525,228

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