Junior Regulatory Affairs Advisor
Core
Support clients in navigating the evolving regulatory landscape for pharmaceutical and life sciences companies, contributing to regulatory strategy and operational projects across the product lifecycle.
Role type
Junior Regulatory Affairs Advisor (Associate)
Builds
Regulatory strategies, submissions, and Health Authority interactions for Life Sciences clients.
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, submission management, Health Authority interaction, regulatory intelligence, process improvement, RIM systems knowledge, analytical skills, problem-solving
Preferred skills
FDA/global regulatory knowledge, Veeva RIM experience, TOPRA/DIA/RAPS certification, European languages (French, Dutch)
Technologies
Veeva RIM
Responsibilities
Help clients navigate global regulatory requirements; Support clients in interpreting EMA, FDA, and National Competent Authority requirements; Contribute to client regulatory strategies and submissions; Support assessments of Regulatory Affairs processes and systems; Turn regulatory information into actionable insights; Support broader Life Sciences client engagements including market access and commercialisation.
Seniority
Junior, hands-on IC