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Director Global Regulatory Leader (GRL) - Early Development Oncology

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Job Description


Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Global Regulatory Leader (GRL) - Early Development Oncology. The position will focus on drug and/or drug-device combination products and is to be based in any of the Janssen locations in the US or EU.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
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.
Global Regulatory Leader for Early Development Oncology Projects (large and small molecules) integrates multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified global regulatory strategies. This individual will also Lead Global Regulatory Team(s) - activities and responsibilities will include, but are not limited to, the development of a global regulatory strategic plan, the facilitation and coordination of team meetings, representation of Global Regulatory Affairs and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful product development globally and to provide input on governance recommendations. Ensures regulatory strategies from an early development perspective (Phase 1-2). Refines regulatory strategies as new data become available and re-assess as necessary. Develops and updates contingency plans for issues that affect study initiation and registration scenarios especially as it relates to CTA and IND activities and ensures strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, and the Target Product Profile. Leads the preparation of regulatory dossiers for submission to Health Authorities and modifies submission plans and aligns with sourcing and Intellectual Property. Establishes Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to Health Authorities. Works with the Global Regulatory Team to provide input for target labeling, 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 support more than one compound within the early development oncology portfolio
Principle responsibilities for GRL, include:
Regulatory Strategy
• Integrate multiple inputs from regional and functional GRT members to create and execute a coherent and unified global regulatory strategy for one or more product (s)
• Develop a regulatory strategic plan and ensure the plan and strategies are refined 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.)
• Accountable for regulatory recommendations for governance processes.
• Develop and update contingency plans for issues that affect study initiation, movement to full development, and registration scenarios.
• Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, and Target Label
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)
• Understanding of procedures for working with HA's.
• Understanding procedures for approaching, influencing HA's.
• Knowledge of history of positions HA's have taken on particular issues
Submissions
• Provide input to and be accountable for the preparation of dossiers for submission to HA (IND/CTAs/NDA / MAA)
• Work with the clinical team to develop clinical trial submission plans
• Modify submission plan and align with sourcing, IP and if appropriate launch strategies
• Establish Rapid Response Team to develop and get buy-in on global strategy for HA responses as needed
• Work with GRT and CDT to comply with local regulatory requirements and commitments
• Knowledge of HA procedures that need to be followed.
• Understanding how a HA perceives, handles and provides feedback to submissions.
• Understanding of individual HA review practices.
Regulatory Input into Other Functions
• Conduct licensing evaluations (as needed)
• Work with the GRT to provide input for Target Label
• As needed, 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


Qualifications
Qualifications:
• Minimum of Bachelor’s/undergraduate or equivalent degree in a scientific or technical discipline required
• Advanced degree (MS, PhD, MD or Pharm D) strongly preferred
• 10+ years of pharmaceutical/biotech industry or health authority experience
• A minimum of at least 6 years of RA or related experience required
• A minimum of at least 4 years of clinical experience is required
• Minimum 4 years of experience within a supervisory capacity or managing teams within matrix environment preferred
• Experience leading interactions with Health Authorities is required
• Diverse therapeutic area experience is preferred
• Working knowledge of WW HA laws, regulations, guidance and global regulation submission routes available for new study drugs is required
• Detailed understanding of competitors in the area and what they are doing in early/late development is required
• General knowledge of labeling aspects of competitors therapeutics is preferred
• Solid understanding of biology and chemistry relevant to the Oncology therapeutic area is preferred
• Experience developing regulatory strategies and an understanding of product development required
• The willingness and ability to travel up to 20% both international and domestic is required.
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-
Other Locations
Europe/Middle East/Africa, North America-United States
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
00001FSW