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Executive Director, Head of Global Regulatory Affairs, Neurology, Immunology and Establised Products

Company: Millipore Corporation
Location: Billerica
Posted on: January 13, 2021

Job Description:

Your role:--As GRA Neurology, Immunology and Established Products,--you--manage a team of--Global Regulatory Leads and Regional Leads (US,--EU and International) driving our programs, ensuring the development of, and supervising regulatory strategies across the portfolio.--Reporting--to--the Head of--Global Regulatory Affairs, you--coordinate--resources and balance--project support across--therapeutic areas, whilst overseeing major Health Authority interactions.--In this leadership position, you--provide strategic oversight for projects, aligned to overall R&D objectives from early development, through initial registration and global expansion, including implementation of new indications and formulations. Actively collaborating with management and cross functional colleagues (including commercial, research, clinical development, medical affairs, business development) at TA level you provide--portfolio level regulatory science insight and broader drug development expertise.--You--will--participate in the overall GRA strategy--and collaborate with peers on the GRA & RDQ Leadership Team to create a united environment and serve as a role model--for--employees. Who You Are: Required Qualifications:?? * You completed a--Bachelor's--degree in science * You gained 12+ years of pharmaceutical/biotechnology industry experience, which shall include 10 years of Regulatory experience (regional or global) and worldwide experience of regulatory submissions and approvals. * You possess a track record of post-marketing activities. * You gained sounds managerial experience * You are a driver of change and innovation * You--are able to--travel domestically and internationally * You are--fluent--English--(written and spoken) Preferred Qualifications? * Advanced degree:--Ph.D.,--Pharm.D--or M.D. * Strong experience in the field of Neurology/ Immunology

Keywords: Millipore Corporation, Billerica , Executive Director, Head of Global Regulatory Affairs, Neurology, Immunology and Establised Products, Executive , Billerica, Massachusetts

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