Regulatory Affairs Director Job
Location: Raritan, NJ, US
Regulatory Affairs Director-7220150520
Janssen Research & Development, LLC, a Janssen Pharmaceutical Company of Johnson & Johnson, is currently recruiting for a Director, North America Regulatory Leader - Oncology. This position will be located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Director, North America Regulatory Leader – Oncology integrates 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, 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 regional (North America) regulatory strategies throughout lifecycle of compounds as appropriate. Refines regional regulatory strategies as new data become available and re-assess as necessary. Develops and updates contingency plans for issues that affect North America 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 North American Health Authorities. When necessary, leads Global Regulatory Team(s) as delegated by the Global Regulatory Leader to develop global marketing approval submission plans and timing, modifies submission plans and aligns with sourcing, Intellectual Property and launch strategies as appropriate. Establishes Rapid Response Teams as necessary to develop and obtain alignment on North America strategy for potential global impact and strategy for responses to Health Authorities. 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. May present to CDT regarding the North America strategy as needed. Participates in and conducts licensing evaluations as needed. May manage a staff, including staff that supports additional portfolio products.
Responsibilities of this position include: Regulatory Strategy; Integrate multiple inputs from regional and functional GRT members to create and execute a coherent and unified regional regulatory strategy for one or more product(s); Refine 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 North America regulatory strategy through participation in other teams (labeling working group, clinical, etc.); Provide input into strategy for pricing and reimbursement as required; Accountable for regulatory recommendations for governance processes; Develop and update contingency plans for issues that affect North America registration scenarios and continued lifecycle management of the product; Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, and Target Label; Compliance; Ensure development and/or implementation of processes and procedural documentation to support compliance with HA and J&J requirements. Recommend ideas for revision of processes internally. Follow-up on regional/local labeling strategies and supporting documentation for labeling; Coordinate and follow-up on HA responses or submission amendments and label update submissions to maintain 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; May lead HA interactions with other junior colleagues or affiliates as needed; Determine timing and strategy for HA meetings; Prepare company staff for interactions; Lead all meetings with Health Authorities (HA) for assigned projects and may lead or participate in other HA interactions for direct reports or junior colleagues as appropriate; 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 (order IND/CTA /NDA/NDS); 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; Establish Rapid Response Team to develop and get buy-in on North America strategy for HA responses as needed; Consider implications or gain alignment on potential global impact in alignment with the GRL. 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 North America Labeling strategy; As a member of the clinical working group, provide regulatory input into clinical study design, conduct, country selection, and monitoring and identify need for any additional studies; May 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; May be asked by CDT to review pertinent product/project-related communications, manuscripts and publications.
Minimum of Bachelors degree in a scientific discipline required. Advanced degree (MS, PhD, MD or Pharm D) strongly preferred. Minimum of 10 years pharmaceutical industry experience required. Experience in medical device, diagnostics and/or combination products preferred. A minimum of 6 years of Regulatory Affairs experience required. Minimum of 4 years experience within a supervisory capacity or managing teams within a matrix environment is required. Wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities is required. Working knowledge of WW HA laws, regulations, guidance and regulation submission routes available for new study drugs is required. US Regulatory Leadership experience is required. International development experience in Oncology is preferred. Ability to maintain knowledge of competitors in the Oncology therapeutic area and what they are doing in early/late development is required. Knowledge of labeling aspects is preferred. Solid understanding of biology and chemistry relevant to the Oncology therapeutic area is strongly preferred. Experience developing regulatory strategies and an understanding of product development is required. Experience managing a portfolio of multiple products is required. This position will require approximately 10-20% travel, both International and Domestic.
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Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Regulatory Affairs
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