Manager, Regulatory Affairs
Core
Lead regulatory affairs activities across EMEA, Asia Pacific, and Latin America to ensure compliant execution of clinical research programs and support the development of innovative medical products.
Role type
Senior Manager, Regulatory Affairs (Clinical Research)
Builds
Regulatory submissions, feasibility assessments, contract discussions, and technical documentation for clinical research programs.
Domain
Clinical research / Pharmaceutical / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission management, ICH GCP compliance, strategic regulatory guidance, project coordination, contract negotiation support, budget review, team leadership, cross-cultural collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and coordinate regulatory and ethics committee submissions across international markets; Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained; Provide expert regulatory guidance on country-specific and international requirements; Review and recommend technical documentation (IMPDs, IBs); Communicate submission status and risks to sponsors and project teams; Support business development with budget reviews, contract negotiations, and proposal preparation; Train, coach, and mentor junior regulatory professionals.
Seniority
Manager, hands-on leadership with mentorship
