Manager, Regulatory Affairs
Core
Lead regulatory affairs activities and oversee submissions across international markets to support the development of innovative medical products and clinical research programs.
Role type
Manager, Regulatory Affairs (Clinical Research)
Builds
Regulatory submissions, feasibility assessments, contract discussions, and technical documentation for clinical research programs.
Domain
Pharmaceutical industry / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission management, strategic regulatory guidance, project coordination, stakeholder management, contract negotiation support, technical documentation review, team leadership and mentoring
Preferred skills
Experience in EMEA, Asia Pacific, and Latin America markets, business development support, cross-cultural collaboration
Technologies
ICH GCP, IMPDs, IBs
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 and recommend technical documentation including IMPDs and IBs; Support business development with budget reviews, contract negotiations, and proposal preparation; Train, coach, and mentor junior regulatory affairs professionals
Seniority
Manager, hands-on leadership with mentoring responsibilities