Client dedicated Global Regulatory Lead
Core
Global Regulatory Lead serving as a business partner and facilitator for regulatory activities across the product lifecycle, from pre-approval to post-approval commercialization.
Role type
Senior IC Global Regulatory Lead (Biopharma)
Builds
Regulatory strategies, filings (INDs, BLAs, MAAs), and product launches for biopharmaceutical products
Domain
Biopharmaceuticals / Global Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, FDA/EMA/PMDA expertise, drug development lifecycle knowledge, orphan drug expertise, regulatory document development, stakeholder coordination, project management, team leadership
Preferred skills
PhD or PharmD, experience in rapidly growing pharma organizations, strategic planning, resource allocation
Technologies
None stated
Responsibilities
Provide strategic regulatory insight on pre- and post-approval activities; guide filing strategies and coordinate cross-disciplinary teams; oversee regulatory vendors; contribute to regulatory filings (INDs, BLAs, MAAs); manage post-approval activities (registration, listing, fees); monitor global regulatory landscape changes; partner with commercial, medical, legal, and quality teams; act as conduit between project teams and global regulatory functions
Seniority
Senior, hands-on IC with leadership responsibilities