The role serves as a senior strategic advisor integrating regulatory, clinical, safety, and commercial inputs to drive executable development strategies across the product lifecycle
Job Summary
The role serves as a senior strategic advisor integrating regulatory, clinical, safety, and commercial inputs to drive executable development strategies across the product lifecycle.
Candidates will act as both Regulatory Lead and Project Lead, directly accountable for authoring key submissions like US INDs and EU/UK MAAs while leading cross-functional matrix teams.
IQVIA is committed to diversity, inclusion, and belonging, empowering employees to power smarter healthcare for everyone everywhere through multifaceted thought processes.
Matching Summary
The role serves as a senior strategic advisor integrating regulatory, clinical, safety, and commercial inputs to drive executable development strategies across the product lifecycle.
Skills & Requirements
Must-have
US and EU regulatory strategy expertise
Authoring INDs, NDAs, BLAs, MAAs
Leading cross-functional development teams
Developing Target Product Profiles and Clinical Plans
Managing project budgets and timelines
Nice-to-have
Experience with orphan drug designations
Trusted client advisory capabilities
Mentoring junior colleagues
Business development proposal authoring
Key Requirements
Master's degree in Life Sciences or equivalent
Minimum 8 years of relevant regulatory experience
Hands-on experience with FDA and EMA/UK procedures
Proven track record leading major regulatory deliverables