Manager, Regulatory Affairs
Core
Lead regulatory affairs activities and oversee submissions across EMEA, Asia Pacific, and Latin America to support the development of innovative medical products and clinical research programs.
Role type
Manager, Regulatory Affairs
Builds
Regulatory submissions, feasibility assessments, and contract discussions for clinical research programs
Domain
Clinical research / Pharmaceutical / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission management, ICH GCP compliance, strategic regulatory guidance, contract negotiation support, team coaching and mentoring, cross-cultural collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and coordinate regulatory and ethics committee submissions across multiple regions; Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained; Provide expert regulatory guidance throughout clinical research projects; Review and provide recommendations on technical and study documentation; Communicate submission status, timelines, risks, and regulatory considerations with stakeholders; Support business development activities by reviewing study budgets and contributing to contract negotiations; Train, coach, and mentor junior regulatory affairs professionals
Seniority
Manager, hands-on leadership with mentoring responsibilities
