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J&J Family of Companies. Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs.
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Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.
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Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands). Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
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Experience establishing productive working relationships with FDA/Center for Drug Evaluation and Research (CDER) and understanding of how the FDA views certain drug development issues is required.
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The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
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Associate Director, Regulatory Affairs. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. This position can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company.
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Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensure strategy is in alignment with NA regional teams, Chemistry, Manufacturing, and Controls (CMC), commercial strategies, and the Target Product Profile.
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Advanced degree (Master’s, PhD, PharmD or MD) strongly preferred. janssen.com and follow us @JanssenGlobal. A minimum of 3 years of Regulatory Affairs experience with focus on the North America region and FDA is required.
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We are Janssen. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. Experience with strategic clinical drug development is required. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k.
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This position will require up to 10% domestic and international travel. Experience in the Pulmonary Hypertension Therapeutic Area is preferred. Solid understanding of Worldwide Health Authority laws (with a focus on FDA), regulations, guidances, and regulatory submission routes available for new study drugs is required.
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Provide regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label. Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional regulatory strategies.
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Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist.
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The ability to maintain knowledge of competitors in the therapeutic area, including labeling aspects and what they are doing in early/late development, is required. Support or lead Due Diligence activities as appropriate.
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Must have strong leadership skills with a proven track record of encouraging long-term learning and development of others. Ensure compliance with internal and external policies and legislation. The anticipated base pay range for this position in all other U.S. locations is $135,000 to $232,300.
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,000 to $267,145. Serve as a member of the Labeling Working Group to create or update the Company Core Data Sheet (CCDS) and contribute to the development of local labels as appropriate.
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market research jobs Title: director Company: J J Family Of Companies
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