Manager, Regulatory Affairs
Core
Lead regulatory affairs activities across multiple international markets, overseeing submissions and ensuring compliance throughout the clinical research lifecycle.
Role type
Manager, Regulatory Affairs
Builds
Regulatory submissions and approvals for clinical research programs
Domain
Clinical research / Pharmaceutical
Deliverable
client delivery
Required skills
Regulatory submission management, ICH GCP interpretation, strategic regulatory guidance, contract negotiation support, team coaching and mentoring, cross-functional stakeholder management
Preferred skills
Experience in EMEA, Asia Pacific, and Latin America markets, business development proposal support
Technologies
None stated
Responsibilities
Lead and coordinate regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America; Provide expert regulatory guidance on country-specific and international requirements; Review technical documentation including IMPDs and IBs; Support business development with contract negotiations and feasibility reports; Train and mentor junior regulatory professionals
Seniority
Manager, hands-on leadership