Servier Pharmaceuticals · 1 day ago
Director, US Regional Regulatory Lead
Boston, KY
Contract
Hybrid
Director/Executive
$198K/yr - $240K/yr
10+ years expServier Pharmaceuticals is a Boston-based, commercial-stage biopharmaceutical company focused on advancing cutting-edge science. The Director, US Regional Regulatory Lead will provide US regulatory strategy leadership and contribute to global regulatory plans, ensuring compliance with FDA requirements.
Health CareMedicalPharmaceutical
Responsibilities
Contributes to the GRT for assigned projects in alignment with the team’s one regulatory voice, providing strategic input on the Target Product Profile (TPP), Company Core Data Sheet (CCDS), business planning, governance, and committees
Accountable for US regulatory strategy including clinical regulatory strategy to leverage expedited pathways and FDA initiatives
Accountable for developing FDA engagement and interaction plans for assigned products, including leading content strategy for briefing documents and information requests, leading the team through meeting preparation and moderating the meeting itself
Synthesizes and communicates the impact of FDA program-specific feedback as well as policy and guidelines
Contributes to innovative approaches that accelerate drug development and leads the IND/NDA/BLA submission strategy to ensure FDA requirements are met
Continually identifies business process gaps that require new or revised processes (and SOP’s) to improve the efficiency of achieving regulatory affairs objectives
Collaborates and plays as a team member, aligning team members around shared goals and enabling each member to contribute their best
As regulatory subject matter expert, provides helpful guidance to peers
Shapes and informs the development of global regulatory product strategy
Oversees the filing and maintenance of applications such as INDs, BLAs, and NDAs
Champions operational and compliance activities for assigned deliverables
Qualification
Required
BS/BA in a relevant scientific discipline
Minimum of 10 years of experience working in Regulatory Affairs or related field
Previous experience as a global or US regulatory lead required and experience in oncology and/or neurology therapeutic areas preferred
Must have prior experience leading multiple FDA meetings
Capable of independently formulating strategy recommendations with minimal input from manager
Strong regulatory strategy leader skilled at working with cross-functional and regulatory teams
Knowledgeable in ICH, FDA guidelines and requirements
Well organized, scientifically driven, detailed oriented, pragmatic
Open minded, respectful and excels at teamwork
Self-directed, solution oriented, excellent at critical thinking and problem-solving
Comfortable with and capable of prioritizing multiple tasks, projects, and objectives
Able to exercise discretion and confidentiality in a consistent and professional manner
Preferred
Advanced degree (PhD, MD, or MS) in a related field such as life sciences, pharmacy, or regulatory affairs preferred
NDA/BLA filing experience is a plus
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 among other great benefits
Company
Servier Pharmaceuticals
Servier Pharmaceuticals is a pharmaceutical company dedicated to therapeutic progress to serve patient needs.
201-500 employees
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)
Funding
Current Stage
Growth StageLeadership Team
David K. Lee
Chief Executive Officer
Pedro Crisanto
Chief Operating Officer R&D, USA
Recent News
2025-12-08
Company data provided by crunchbase