Senior Director, Global Regulatory Leader
Janssen a member of Johnson & Johnson's Family of Companies, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in pulmonary hypertension, oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. 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.janssen.com
We are currently recruiting a Global Regulatory Leader (Senior Director) for our Global Regulatory Affairs organization. The position is preferably based in one of the following locations; Beerse (Belgium), Raritan NJ (USA) or Titusville NJ (USA), but other locations may also be considered.
As Senior Director, Global Regulatory Leader (GRL), you will:
- Bring innovative regulatory approaches, deeply rooted in science to lead the team in discussion with global health authorities to find the best development strategies for novel therapies in the areas where no other precedents exist.
- Be responsible for the development, implementation and maintenance of robust global regulatory strategies for transformational therapies targeted to address unmet needs in retinal diseases in different phases of development.
- Drive the execution of the regulatory strategies for select projects through close collaboration with functional areas and ensure alignment with the overall Therapeutic Area strategy.
- Lead the Global Regulatory Team (GRT) and contribute optimally on multiple cross-functional teams including but not limited to the Compound Development Team, Global Dossier Team, Clinical Working Group, and the Labeling Working Group.
- Ensure that regulatory strategies also take into account non-regulatory market access issues (e.g., health technology assessments, payor demands)
- Ensure, facilitate and/or lead the development or enhancement of constructive relationships and associations with Health Authorities and leaders with vision in appropriate business critical settings.
- Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
- Lead the preparation and participate in meetings with FDA, EMA, PMDA, CDE, Health Canada and other Health Authorities (HAs) as required.
- Serve as a member of LWG to create or update the CCDS and contributes 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.
- A minimum of a B.S. or undergraduate in a life sciences or technical discipline is required
- An advanced degree (e.g., M.S., Ph.D., M.D.) is highly desirable
- A minimum of 15 years in a Global Regulatory Affairs, Drug Development, R&D or health authority role is required
- Minimum 5 years of regulatory affairs leadership experience is beneficial
- Significant experience in the development and execution of global regulatory strategies, the drug development process, regulatory compliance, and regulatory strategy for product lifecycle management is required
- Experience establishing productive working relationships with Health Authorities and gaining a deep understanding of how regulators view certain drug development issues is required
- A proven ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects is beneficial;
- Solid understanding of biology and chemistry relevant to therapeutic area is an asset
- Diverse therapeutic area experience (e.g. oncology, immunology, vaccines, gene therapy etc.) would be beneficial
- Experience leading a matrixed, diverse, global team is preferred
- Experience leading direct reports and being responsible for their development is required
- It may be required to travel up to 20% domestic and internationally.
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-New Jersey-Raritan-920 US Highway 202Other Locations
United States-Washington-Seattle, United States-New Jersey-Titusville, United States-New York-New York, United States-Ohio-Cincinnati, United States-Pennsylvania-Spring House, United States-Texas-Houston, United States-Texas-San Angelo, United Kingdom-England-High Wycombe, Netherlands-South Holland-Leiden, United States-California-San Francisco, United States-Virginia-Richmond, United States-North Carolina-Charlotte, United States-Pennsylvania-Philadelphia, United States-Massachusetts-Boston, North America-United States-North Carolina-Raleigh, North America-United States-Indiana-Indianapolis, North America-United States-Michigan-Detroit, North America-United States-Texas-Dallas, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, 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-Illinois-ChicagoOrganization
Janssen Research & Development, LLC (6084)Job Function
Regulatory AffairsRequisition ID
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