Associate Director, Global Regulatory Leader

Job content

The Associate Director, Global Regulatory Leader (m/f/x, 100%)

Janssen, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director, Global Regulatory Leader, supporting the Infectious Disease Therapeutic Area. The position is preferably based in Beerse (Belgium), Raritan NJ (USA) or Titusville NJ (USA). Other locations could also be considered.
Janssen 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.janssenpharmaceuticalsinc.com

Main Responsibilities:
- Current responsibilities are to support the development of HIV products and commercial and Global Public Health business
- Represents Global Regulatory Affairs and provides regulatory expertise to the Product Development Team and Clinical Team to facilitate successful product development support globally and to provide input on governance recommendations, including joint team meetings with external collaborators. - Represents Regulatory viewpoint and expertise on the Product Development Team, including regulatory risk/benefit evaluations associated with proposed strategies; Provides input into strategy for pricing and reimbursement and/or access strategies
- As a member of the Product Development Team, provides feedback to Discovery and other functions that may translate into potential new uses. Participates in and conducts licensing evaluations as needed.
- As a member of the Clinical Team, provides input on study design, conduct, country selection, and monitoring and identifies need for any additional studies
- Reviews pertinent product/project-related communications, manuscripts and publications

- Leads, facilitates and coordinates 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. - Integrates multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified global regulatory strategies.
- Ensures regulatory strategies throughout lifecycle of products as appropriate. Refines regulatory strategies as new data become available and re-assess as necessary.
- Develops and updates 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/access strategy, and the Target Product Profile.
- Leads the preparation of regulatory dossiers for submission to Health Authorities/notified bodies. Responsibilities include: preparation, editing and critical review of both investigational and marketing applications; correspondence and direct interaction with Health Authorities. Establishes Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to Health Authorities, develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product
- 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 a Labeling strategy. Follows-up on regional/local labeling strategies and supporting documentation for labeling. Coordinates and follows-up on variations and label update submissions to keep product compliance
- Tracks information on submissions and approvals in collaboration with regional RLs and CMC group (if appropriate)

- Evaluates the global regulatory landscape to proactively interpret and shape J&J policies and provide J&J comments on Health Authority guidance’s to support faster access to J&J innovative products. Shaping the external environment.
- Works and may lead in a matrix organization. Responsibilities include training on regulatory requirements and leadership on external influencing and commenting on new regulations, development and/or implementation of processes and procedural documentation to support compliance with HA and J&J requirements.