Regulatory strategy development for early-phase programs
Preparation and submission of inds and ctas
Experience with veeva vault regulatory systems
This role focuses on the tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development
Job Summary
This role focuses on the tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development.
The successful candidate will prepare, review, and submit regulatory documents such as INDs and CTAs while coordinating technical content across CMC, non-clinical, and clinical sections.
As a subject matter expert, the incumbent will serve as the primary contact for regulatory authorities like the FDA and EMA, managing meetings and briefing packages.
Matching Summary
This role focuses on the tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development.
Skills & Requirements
Must-have
Regulatory strategy development for early-phase programs
Preparation and submission of INDs and CTAs
Experience with Veeva Vault regulatory systems
Primary contact for FDA and EMA interactions
Cross-functional collaboration with CMC and quality teams
Nice-to-have
Proactive approach to solving complex challenges
Deep experience in antibody-drug conjugates
Leadership in department infrastructure development
Expertise in global regulatory compliance
Key Requirements
Hands-on expertise in regulatory affairs
Experience with regulatory systems like Veeva Vault
Ability to manage timelines and meet regulatory milestones