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Associate Director NA Regulatory Leader

Company: J&J Family of Companies
Location: Cherry Hill
Posted on: September 21, 2022

Job Description:

Janssen Research and Development LLC. is recruiting for an Associate Director, North America Regulatory Leader. The role is open to multiple locations in NJ or PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Research and Development, LLC. is part of the Janssen Pharmaceutical Companies. Key Responsibilities:

  • Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist
  • Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional regulatory strategies
  • Be responsible for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development
  • Drive the execution of regulatory plan for select projects through close collaboration with multiple functional areas
  • Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with NA regional teams, CMC, commercial strategies, and the Target Product Profile
  • Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands)
  • Own the preparation of regulatory dossiers for submissions to US and Canada.
  • Lead the preparation and participate in meetings with Health Authorities (HAs) in US and OUS markets.
  • Serve as a member of the Labeling Working Group to create or update the CCDS and contribute to the development of local labels as appropriate.
  • Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label
  • Ensure compliance with internal and external policies and legislation
  • Support or lead Due Diligence activities as appropriate
  • Results and Performance Driven/Initiative: Assumes personal ownership and accountability for business results and solutions; you can easily identify a problem, obstacle or opportunity and act to address current or future problems or opportunities. QualificationsExperience and Skills: Education:
    • Minimum of a Bachelors degree in a scientific field (required)
    • Advanced degree (MS, PhD, MD or Pharm D) (preferred) Required:
    • A minimum of 10 years experience in either pharmaceutical industry, medical device industry, consumer industry or health authority regulated industry
    • At least 6 years of Regulatory Affairs experience required with focus on the NA region and FDA
    • At least 4 years experience within a supervisory capacity or managing teams within a matrix environment
    • Experience establishing productive working relationships with FDA/CDER and gaining a deep understanding of how the FDA views certain drug development issues
    • Solid understanding of WW HA laws (with a focus on FDA), regulations, guidances and regulatory submission routes available for new study drugs
    • Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects
    • Impact and Influence: Able to persuade, convince, or influence others, to gain commitment on an idea or a course of action.
    • Organization Awareness: Understands the power relationships in ones own organization and in other organizations.
    • Self-Awareness and Flexibility: Keeps a cool head and acts professionally under stressful conditions; puts the interests of the enterprise above their own; can adapt to, and work effectively within a variety of situations, and with various individuals or groups.
    • Strategic and Conceptual Thinking: Driven to envision a better future; take any role or job and makes it better. Able to identify key or underlying issues in sophisticated situations. Preferred:
    • Experience in pulmonary hypertension
    • Organization and Talent Development: A proven track record of encouraging the long-term learning or development of others. Other:
    • This position will require approximately 10% travel, both International and Domestic. At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary LocationUnited States-New Jersey-Cherry Hill-1820 Chapel AveOther LocationsNorth America-United States-New Jersey, North America-United States-PennsylvaniaOrganizationJanssen Research & Development, LLC (6084)Job FunctionRegulatory AffairsRequisition ID2206072349W

Keywords: J&J Family of Companies, Cherry Hill , Associate Director NA Regulatory Leader, Executive , Cherry Hill, New Jersey

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