Associate Director, Global Regulatory Lead

SERVIER MONDE

13d • Remote

About The Position

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. The Associate Director, Global Regulatory Lead (GRL) in Neurology supports neurology programs across all phases of clinical development. The individual will be accountable for developing and executing Regulatory strategies and independently represent the department on program teams. The role involves strong cross-functional collaboration with internal and external partners, including Clinical Development, Biostatistics, Medical Writing, Clinical Pharmacology and others, to advance drug candidates in an efficient and scientifically rigorous manner. Key responsibilities include developing Regulatory strategies in collaboration with the GRT, from late research to post marketing. At the project level, the individual will lead the Global Regulatory Team (GRT) and represent Regulatory at the project/asset core team.

Requirements

• Bachelor of Science in (BS) in a relevant scientific discipline required with 8 years of experience in Regulatory Affairs; advanced degree (MS, PharmD, PhD/MD) preferred.
• Previous experience as a GRL in Neurology Rare Diseases is required; experience in multiple therapeutic areas is a plus. Equivalent experience in Neurology at a Regulatory Agency will also be considered.
• Solid understanding of all phases of drug development required. Experience in early development is highly desirable. Experience in multiple stages of drug development is a plus.
• Knowledge of ICH, FDA and EMA guidelines is required. Experience with Japan and China is a plus.
• Experience leading in a matrixed organization. Works collaboratively to deliver goals within a cross-functional, multicultural environment.
• 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.

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)

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees