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)

P
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.

  • 23 Days Ago

P
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...
  • 23 Days Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Mount Holly, NJ FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Florham Park, NJ FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Bridgewater, NJ FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Paramus, NJ FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

S
Regulatory Affairs Specialist
  • Sally Beauty Holdings, Inc.
  • Denton, TX
  • Review labels of private label products for regulatory compliance in the US and applicable international markets. Review...
  • 3/28/2024 12:00:00 AM

K
Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electroni...
  • 3/28/2024 12:00:00 AM

C
Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Product Regulatory Affairs work includes: Directing submission development of product registration, progress reports, su...
  • 3/28/2024 12:00:00 AM

G
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...
  • 3/27/2024 12:00:00 AM

P
Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 3/27/2024 12:00:00 AM

A
Regulatory Affairs Specialist
  • Akkodis
  • Irvine, CA
  • Akkodis is seeking an Regulatory Affairs Specialist for a company located in Candidates need to be local to a Irvine ,CA...
  • 3/26/2024 12:00:00 AM

T
Regulatory Affairs Specialist
  • Tephra
  • Edison, NJ
  • Description: The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory...
  • 3/26/2024 12:00:00 AM

T
Regulatory Affairs Specialist
  • The Judge Group
  • Horsham, PA
  • Regulatory Affairs Specialistreq38824Employment Type: RegularLocation: HORSHAM,PAHave you ever enjoyed Arnold, Brownberr...
  • 3/26/2024 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
$321,628 to $526,202

Top Regulatory Affairs Executive in Wilmington, NC
On average, a Doctorate Degree is the highest level of education for a Top Regulatory Affairs Executive.
February 04, 2020
Top Regulatory Affairs Executive in Champaign, IL
If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
February 06, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020