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Job #02670

About our client Our client, a clinical site dedicated to oncology patients, has an immediate need of two experienced clinical research nurses. Position Location Senior Director of Regulatory Affairs Los Angeles, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Evaluate and integrate input from both regional and functional members of the Global Regulatory and Product Development Team for the assigned product(s) 2) Develop strategic regulatory approach to the Global Regulatory Plan and global regulatory input to the development plan to achieve optimal development and life cycle management plans 3) Regulate strategy optimization to support timely registration of assigned products 4) Provide regulatory risk assessment and effective regulatory mitigation plans 5) Ensure execution of regional regulatory strategies in accordance with approved global development strategy 6) Lead the Global Regulatory Team to create a coherent and globally integrated regulatory strategy 7) Provide guidance on all regulatory matters related to the drug development process to ensure timely start of clinical trials (IND/CTA) and approval of marketing applications (NDA/MAA) 8) Represent the regulatory perspective as a member of the Product Development Team 9) Develop regulatory readiness, including negotiation tactics and contingency planning 10) Provide input/leadership into interactions with health authorities 11) Develop core data sheet that is consistent with development data and commercial objectives 12) Review input and agreement of documents intended for regulatory submission 13) Develop a target product profile with input from functional members Requirements 1) Advanced degree in a health-related science field (preferred) 2) 10 – 14 years of pharmaceutical industry experience, with 8 years of (progressive) responsibility in regulatory affairs involving US and/or EU liaison 3) Extensive knowledge of US FDA and EU/EMEA regulations and guidelines 4) Outstanding interpersonal, communication and organizational skills 5) Excellent leadership and management skills 6) Proven planning and tactical skills