Sr Director Regulatory Affairs MedTech for LCI

Company: Disability Solutions
Location: Redwood City
Posted on: March 20, 2023

Job Description:

Sr. Director, Regulatory Affairs - MedTech for the Lung Cancer Initiative (LCI) & Interventional Oncology Location: Raritan, New Jersey; Bay Area, California; however, flexible arrangements for other US site locations can be discussed At J&J, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and curing lung cancer. The LCI strives to eliminate lung cancer one patient at a time by developing comprehensive solutions through consumer products, diagnostics, medical devices, and pharmaceuticals. As the lead for MedTech, the Sr RA Director plays a key role in ensuring that regulatory strategies are established and implemented in service of the LCI. Is this you? If yes, APPLY. https://www.jnj.com/credo/ Key Responsibilities:

• Provide leadership, guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the potential outcomes for different regulatory strategies, and setting the strategy for submissions of product registration documents to health authorities
• Provide regulatory expertise and knowledge of regulatory requirements to develop regulatory strategic plans for cross-sector and cross-platform projects
• Partner with MedTech Franchise and Platform RA leadership teams to ensure robust, optimum regulatory strategies are established and in service of LCI
• Drive collaboration within MedTech and with cross-functional partners and serves a critical role as the MedTech RA lead to make the connections across disparate priorities
• Develop and carry out the governance model for MedTech RA LCI related activities and strategies, including cross-platform ways of working
• Serve as the counterpart to the Pharm RA LCI Lead
• Assist in the design of clinical studies required for regulatory approvals
• Monitor and analyze regulatory agency activities in areas of interest to the LCI and assess the potential impact on LCI programs. Take a global view of regulatory strategy and help teams navigate regional requirements and the possible interplay between key regulatory agencies.
• Examine Global regulatory strategy options, provide relevant guidance/precedents, and stay abreast of the regulatory and competitive landscape.

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