J&J Family of Companies Director North America Regulatory Leader (NARL) - Oncology in New York, New York
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, North America Regulatory Leader (NARL) - Oncology. The ideal location for this position Raritan, NJ however other locations throughout the U.S. may be considered.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
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.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. 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
The Director, North America Regulatory Leader you will integrate multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified regional regulatory strategies. Leads Regional Regulatory Team(s) - activities and responsibilities will include, but are not limited to:
the facilitation and coordination of team meetings and representation of Global Regulatory Affairs and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful marketed product development support globally and to provide input on governance recommendations
Ensures regulatory strategies throughout lifecycle of compounds as appropriate. Refines regulatory strategies as new data become available and re-assess as necessary
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 Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial strategy, and the Target Product Profile.
Leads the preparation of regulatory dossiers for submission to Health Authorities. Leads Global Regulatory Team(s) to develop global marketing approval submission plans and timing, modifies submission plans and aligns with sourcing, Intellectual Property and launch strategies as appropriate.
Works with the Global Regulatory Team to provide input for target labeling, and the Labeling Working Group in making strategic decisions, including the creation of Labeling strategy.
As a member of the CDT, provides feedback to Discovery and other functions that may translate into potential new uses. Participates in and conducts licensing evaluations as needed. May manage a staff, including staff that supports additional portfolio products.
Additional Responsibilities of this position include:
Regulatory Strategy; Integrate multiple inputs from regional and functional GRT members to build and execute a coherent and unified regional regulatory strategy for one or more product(s); Refine and improve regulatory strategy as new data become available and re-assess as necessary;
Lead, facilitate, and coordinate GRT meetings; Represent Regulatory viewpoint and expertise on the CDT, including regulatory risk/benefit evaluations associated with proposed strategies;
Provide direction on implications for regulatory strategy through participation in other teams (labeling working group, clinical, etc.); Provide input into strategy for pricing and reimbursement; Accountable for regulatory recommendations for governance processes;
Ensure development and/or implementation of processes and procedural documentation to support compliance with HA and J&J requirements;
Follow-up on regional/local labeling strategies and supporting documentation for labeling; Coordinate and follow-up variations and label update submissions to keep product compliance;
Track information on submissions and approvals in collaboration with regional RLs and CMC group; HA Interactions in collaboration with Regional and/or local Regulatory Leader, as applicable;
Determine timing and strategy for HA meetings; Prepare company staff for interactions; When appropriate lead meetings with Health Authorities (HA); Develop strategy for providing responses to HA questions (ensure alignment with global strategy); Negotiate regional labeling with HAs (ensure alignment with global strategy) as appropriate;
Submissions; Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA/MAA/IRD/IND/CTA); Work with the clinical team to develop clinical trial submission plans; Work with the GRT to develop global marketing approval submission plan and timing; Modify submission plan and align with sourcing, IP and launch strategies;
Build Rapid Response Team to develop and get consensus on global strategy for HA responses as needed; Work with GRT and CDT to comply with local regulatory requirements and commitments;
Regulatory Input into Other Functions; Conduct licensing evaluations (as needed); Work with the GRT to provide input for Target Label; Co-lead the Labeling Working Group in making strategic decisions, including creation of Labeling strategy;
As a member of the clinical team, provide input on study design, conduct, country selection, and monitoring and identify need for any additional studies; Provide feedback to Discovery and other functions that may translate into potential new compounds and uses;
Provide input to commercial Drug Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy;
Provide input into risk/benefit assessment; Work with GRT to direct, manage and resolve any “issues” as required with dedicated resources; Consult with Regulatory Legal and Healthcare Compliance to address pertinent issues; As part of CDT, review pertinent product/project-related communications, manuscripts and publications
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Minimum of Bachelors or undergraduate degree in a scientific or technical discipline required;
Advanced degree (MS, PhD, MD or Pharm D) would be an asset
Minimum of 10 years experience in either pharmaceutical/biotech industry, medical device industry, consumer health industry or health authority regulated industry is required
At least 6 years of Regulatory Affairs experience required;
Minimum of 4 years experience within a supervisory capacity or managing teams within matrix environment required;
Wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities is required;
Detailed knowledge of North American HA laws, regulations, guidance and regulation submission routes available for new study drugs is required
Working knowledge of WW HA laws, regulations, guidance and regulation submission routes available for new study drugs is beneficial
Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects required;
Solid understanding of biology and chemistry relevant to therapeutic area is preferred;
Experience developing regulatory strategies and an understanding of product development required;
Experience managing a portfolio of multiple products required;
Oncology therapeutic experience is preferred
This position will require approximately 10 % travel, both International and Domestic.
Diversity and inclusion are at our core. They’ve been part of how we’ve worked since our foundation over 130 years ago, and our commitment to respect your diversity is enshrined in our Credo. We are nothing without your unique perspective, and our work is about you, your colleagues, and the world we care for, coming together. To achieve this, we create a deep sense of belonging – a culture where you are valued, and your ideas are heard. In turn, you advance this culture for everyone. Diversity and inclusion at Johnson & Johnson means: ‘You Belong.’
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.
United States-New Jersey-Raritan-920 US Highway 202
North America-United States-North Carolina-Raleigh, North America-United States-Indiana-Indianapolis, North America-United States-Texas-Dallas, North America-United States-Maryland-Baltimore, North America-United States-Pennsylvania-Pittsburgh, North America-United States-Georgia-Atlanta, United States-Pennsylvania-Horsham, United States-California-Irvine, United States-California-San Diego, United States-Delaware-Wilmington, United States-Florida-Jacksonville, United States-Florida-Miami, United States-Florida-Tampa, United States-Massachusetts-Raynham, United States-New Jersey-Titusville, United States-New York-New York, United States-Ohio-Cincinnati, United States-Pennsylvania-Malvern, United States-Pennsylvania-Spring House, United States-Texas-San Angelo, United States-Washington-Seattle, United States-California-San Francisco, United States-Virginia-Richmond, United States-North Carolina-Charlotte, United States-Pennsylvania-Philadelphia
Janssen Research & Development, LLC (6084)
J&J Family of Companies
- J&J Family of Companies Jobs