Associate Director, North America Regulatory Lead, Global Regulatory Affairs, Immunology

Johnson and Johnson

Janssen Research & Development, LLC is recruiting for an Associate Director, North America Regulatory Lead, Global Regulatory Affairs (GRA), Immunology. The preferred located is Springhouse, PA, however flexible arrangements for other US site locations may be considered.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

The Associate Director, North America Regulatory Lead, GRA Immunology, will be responsible for leading North America regulatory strategy, working closely with Global Regulatory Leader (GRL) for regulatory activities related to large and small molecule compounds in development and/or marketed products in the assigned portfolio within the Immunology therapeutic area including but not limited to Rheumatology, Gastroenterology, and Dermatology.

Key responsibilities include, but not limited to, the following:

  • Responsible for developing and implementing North American regulatory strategy.
  • Leads and facilitates cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams (e.g., Clinical and Labeling working groups Dossier submission teams,).
  • Provides regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) if requested
  • Serves as primary contact with North American Health Authorities (HA) &/or Operating Companies.
  • Within the context of the global strategy, determines timing, appropriate NA regional strategy and content for all HA meetings.
  • Lead and/or participate in meetings with NA regulatory agencies as appropriate.
  • Prepare company personnel for interactions with HA.
  • Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
  • Lead and oversee the preparation of dossier content for INDs, BLA/NDA according to the strategic plan for the region and health authority commitments.
  • Performing critical review of submission documents to ensure compliance with regulatory requirements.
  • Serves as a member of Labeling Working Group (LWG) to derive and update proposed Company Core Data Sheet (CCDS) and US Package Insert (USPI) based on target label.
  • Participates in development of labeling negotiation strategies.
  • Provides input into strategy with respect to clinical study design.
  • Negotiates and manages NA regional post-approval commitments.
  • Partner with GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and immunology-specific issues.
  • Stay ahead of current and pending immunology approvals and maintain working knowledge of laws, guidances and requirements related to immunology, in addition to general regulatory knowledge.

Qualifications

Qualifications

To be successful in the role, you will have the following experience and skills:

  • A minimum of a B.S. or undergraduate degree is required, a degree in a life-sciences is discipline is highly preferred
  • An advanced degree (e.g., M.S., Ph.D. PharmD) is preferred
  • Minimum of 8 years pharmaceutical, medical device or health regulated industry experience with knowledge of the drug development process and regulatory submission and approval process is required.
  • A Minimum 5 years of experience working in a regulatory affairs function is preferred.
  • An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required
  • Therapeutic area experience in immunology (i.e. rheumatology, gastroenterology, dermatology) is beneficial
  • Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
  • Previous experience interacting with health authorities is required
  • Experience critically reviewing and compiling regulatory documents is required
  • A previous track record of success working successfully within a cross functional team environment as an individual contributor and decision maker is required
  • A proven track record to work successfully within a collaborative team environment, build positive relationships as an individual contributor is required
  • A previous track record of success of effectively prioritizing assignments for multiple projects simultaneously is required.
  • 10% domestic travel and potential international travel maybe needed

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 Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

North America-United States-North Carolina-Raleigh, North America-United States-Indiana-Indianapolis, North America-United States-Maryland-Baltimore, North America-United States-Pennsylvania-Pittsburgh, North America-United States-Georgia-Atlanta, North America-United States-Pennsylvania-Chesterbrook, United States-New Jersey-Raritan, United States-California-Irvine, United States-California-San Diego, United States-Delaware-Wilmington, United States-Florida-Jacksonville, United States-Florida-Tampa, United States-Illinois-Chicago, United States-New Jersey-Titusville, United States-New York-New York, United States-Pennsylvania-Spring House, United States-Texas-Houston, United States-Texas-San Angelo, United States-California-San Francisco, United States-North Carolina-Charlotte, United States-Massachusetts-Boston, United States-Washington-Seattle, United States-District of Columbia-Washington

Organization

Janssen Research & Development, LLC (6084)

Job Function

Regulatory Affairs

Requisition ID

2105930661W

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Confirmed a day ago. Posted 30+ days ago.

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