The role serves as a trusted strategic advisor and primary point of contact for biopharmaceutical clients regarding global drug development
Job Summary
The role serves as a trusted strategic advisor and primary point of contact for biopharmaceutical clients regarding global drug development.
Candidates will lead cross-functional matrix teams to deliver integrated regulatory strategies and executable development plans across the product lifecycle.
This position requires direct accountability for authoring key regulatory submissions including US INDs, NDA/BLA, and EMA/UK MAA-related deliverables.
Matching Summary
The role serves as a trusted strategic advisor and primary point of contact for biopharmaceutical clients regarding global drug development.
Skills & Requirements
Must-have
US and EU regulatory strategy expertise
Authoring US 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
Strong client advisory and communication skills
Mentoring junior colleagues and leads
Business development proposal authoring
Resilience in high-pressure environments
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