Associate Director, Global Regulatory Lead
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Date posted: Dec 10, 2025
Location: Boston, MA (US East Coast, 100% remote within US East Coast). Some travel required (5-10%, domestic/international).
Job Requisition ID: 10534
Type of Contract: Full-time Employment / Unlimited.
About Servier
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.
Role Summary
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.
Primary Responsibilities
- Lead the Global Regulatory Team (GRT) for assigned project(s) spanning late research to post‑marketing stages.
- 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.
- 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. Design regulatory submission plans in collaboration with the GRT.
- Provide strategic direction 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 as appropriate, in close collaboration with RRLs/LRA.
- Collaborate with labeling lead for 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.
- Interface with external partners (e.g., CDx providers, licensing partners) and participate in in‑licensing/out‑licensing and due diligence.
- Conduct regulatory impact assessment in case of new findings (quality, efficacy or safety).
Education and Required Skills
- Bachelor of Science in a relevant scientific discipline required (8+ years of regulatory affairs experience). Advanced degree (MS, PharmD, PhD/MD) preferred.
- Previous experience as a GRL in Neurology Rare Diseases required; experience in multiple therapeutic areas a plus. Equivalent experience in a regulatory agency also considered.
- Solid understanding of all phases of drug development; early development experience highly desirable.
- Knowledge of ICH, FDA and EMA guidelines required; experience with Japan and China a plus.
- Experience leading in a matrixed organization; collaborates effectively across cross‑functional, multicultural teams.
- Ability to make sound judgment, 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.
Travel and Location
Some travel required (around 5-10%), domestic and/or international.
This role is 100% remote in the US East Coast.
Employment Type
Full‑time
Seniority Level
Director
Job Function
Legal
Industries
Pharmaceutical Manufacturing
Salary Range
$170,000 - $200,000. Pay position within the range will be based on factors such as education, qualifications, experience, geographic location, performance and business needs. Employees may be eligible for short‑term and long‑term incentive programs and a comprehensive benefits package (medical, dental, vision, flexible time off, 401(k), life and disability insurance, recognition programs). For more information, please visit this link.
Commitment to Diversity, Equity & Inclusion
Servier is committed to modeling diversity, equity, and inclusion within the industry. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Referral Information
Referrals are encouraged and may increase interview chances.
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