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Servier Pharmaceuticals · 9 hours ago

Associate Director, Global Regulatory Lead

United States

Full-time

Remote

Lead/Staff, Director/Executive

$170K/yr - $200K/yr

8+ years exp

Servier Pharmaceuticals is a Boston-based, commercial-stage biopharmaceutical company focused on advancing cutting-edge science and addressing underserved therapeutic areas. The Associate Director, Global Regulatory Lead will develop and execute regulatory strategies for neurology programs, ensuring efficient collaboration across various teams to advance drug candidates through all phases of clinical development.

Health CareMedicalPharmaceutical

H1B Sponsor Likely

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)

Qualification

Regulatory AffairsNeurology experienceDrug development phasesICHFDAEMA guidelinesMatrix organization leadershipAnalytical skillsProblem-solving skillsInfluencing skillsAction-orientedResults drivenVerbal communicationWritten communicationConflict resolution

Required

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

Preferred

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 among other great benefits (all benefits are subject to eligibility requirements)

Company

Servier Pharmaceuticals

Servier Pharmaceuticals is a pharmaceutical company dedicated to therapeutic progress to serve patient needs.

Founded in 2018

Boston, Massachusetts, USA

201-500 employees

https://www.servier.us/

H1B Sponsorship

Servier Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (4)

2023 (4)

2022 (3)

2021 (15)

2020 (2)