[Remote] Associate Director, Global Regulatory Lead

Note: The job is a remote job and is open to candidates in USA. Servier is a Boston-based, commercial-stage biopharmaceutical company focused on advancing cutting-edge science in underserved therapeutic areas. The Associate Director, Global Regulatory Lead will support neurology programs across all phases of clinical development by developing and executing regulatory strategies and collaborating with various internal and external teams to advance drug candidates efficiently. Responsibilities • Lead the Global Regulatory Team (GRT) for the assigned project(s). Assignments may include assets and / or indications from late research to post-marketing stage • Evaluate current regulatory requirements and competitive landscape across major markets to support regulatory strategy needed to deliver the Target Product Profile. Present options and recommendations to expedite path to market, as applicable • Analyze and address complex issues, providing Regulatory solutions and guidance to the Project Team(s) to help shape and support the development strategy • Evaluate Regulatory risks and recommend mitigation strategies to the Project Team(s) and Regulatory Leadership • Provide support to Regional Regulatory Leads (RRLs)/Local Regulatory Affairs (LRA) in key markets to facilitate registration procedures. Responsible for designing regulatory submission plans in collaboration with the GRT • Provide strategic direction to teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications • Participate in meetings with FDA, EMA, PMDA and other Health Authorities (HAs) as appropriate, in close collaboration with RRLs/ LRA • Collaborate with Labeling Lead for the development of Company Core Data Sheet (CCDS), USPI and SmPC as needed • Provide support to Market Access in key markets for the core value dossier • May interface with external partners (e.g., CDx providers, licensing partners) and participate in in-licensing / out-licensing and due diligence • Responsible for regulatory impact assessment in case of new findings (quality, efficacy or safety) Skills • Bachelor of Science in (BS) in a relevant scientific discipline required with 8 years of experience in Regulatory Affairs • Previous experience as a GRL in Neurology Rare Diseases is required • Solid understanding of all phases of drug development required • Knowledge of ICH, FDA and EMA guidelines is required • Experience leading in a matrixed organization • Demonstrated ability to make sound judgement, adapt to changing business needs, and manage multiple priorities in complex settings • Demonstrated analytical and problem-solving skills • Excellent verbal and written communication skills • Ability to influence others and resolve conflicts • Action-oriented and results driven • Advanced degree (MS, PharmD, PhD/MD) • Experience in multiple therapeutic areas • Experience with Japan and China • Experience in early development • Experience in multiple stages of drug development Benefits • Short-Term and Long-Term incentive programs • Medical • Dental • Vision • Flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off) • 401(k) • Life and disability insurance • Recognition programs Company Overview • Servier is an pharmaceutical company governed by a non-profit foundation. It was founded in 1954, and is headquartered in Suresnes, Ile-de-France, FRA, with a workforce of 10001+ employees. Its website is Apply tot his job