Manager, Regional Regulatory Lead - LCM
Core
Regional Regulatory Lead managing product relationships with health authorities (FDA/EMA) to ensure timely regulatory outcomes and alignment with global strategy.
Role type
Manager, Regional Regulatory Lead
Builds
Regulatory submissions, briefing books, and product approval pathways for biotech therapies
Domain
Biotechnology / Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission experience, Health authority interaction, Regional regulatory knowledge (EU/US/Japan), Product development lifecycle management, Strategic risk assessment, Cross-functional collaboration
Preferred skills
Advanced degree (MS/PhD/MD/MBA), Clinical or device foundation, Experience with complex matrix environments
Technologies
Veeva
Responsibilities
Manage assigned product relationship with health authorities and negotiate regulatory outcomes; Develop regional regulatory knowledge and guide internal stakeholders on filing pathways; Support core document preparation and product filing activities; Contribute to global regulatory strategy and competitive intelligence; Maintain regulatory systems for compliance tracking.
Seniority
Manager, hands-on IC