Global Life Science Hub · 22 hours ago
Global Vice President Regulatory
United States
Full-time
Remote
Director/Executive
15+ years expGlobal Life Science Hub is recruiting on behalf of a commercial-stage biologics manufacturer that is entering a critical phase for global regulatory leadership. The Global VP / SVP of Regulatory Affairs will take full ownership of worldwide regulatory strategy and serve as the primary regulatory representative with the FDA and international agencies.
Staffing & Recruiting
Hiring Manager
Christopher Antoniou
Responsibilities
Lead and execute global regulatory strategy for biologics and biosimilars across US and international markets
Serve as the primary point of contact with FDA, EMA, and global health authorities , including leading formal meetings and negotiations
Oversee preparation, submission, and maintenance of INDs, BLAs, MAAs, and post-approval filings
Build, mentor, and lead a high-performing global Regulatory Affairs organisation
Provide regulatory leadership for commercial manufacturing readiness, comparability, and global supply strategy
Anticipate and mitigate regulatory risks across development, CMC, and commercial activities
Drive labeling strategy, lifecycle management, and post-approval expansions
Provide regulatory due diligence support for business development, partnerships, and acquisitions
Ensure robust post-market regulatory compliance , including safety reporting and regulatory commitments
Act as a trusted regulatory advisor to senior leadership and Board-level stakeholders
Qualification
Required
Advanced degree in a scientific discipline required (PhD or PharmD strongly preferred)
15+ years Regulatory Affairs experience within biopharma, including senior global leadership roles
Demonstrated success leading end-to-end regulatory strategy for biologics and/or biosimilars, including successful BLA/MAA approvals
Deep expertise across CMC, Clinical, and Commercial Regulatory Affairs
Proven experience supporting products moving into commercial-scale manufacturing and global distribution
Extensive direct interaction with FDA, EMA, and international regulatory agencies
Track record of building and leading global regulatory teams in growth-stage organisations
Strategic yet pragmatic leader comfortable operating in fast-paced, execution-focused environments
Strong communicator with the ability to influence at Executive, Board, and Agency levels
Experience thriving in entrepreneurial or mid-sized organisations, not just large pharma
Company
Global Life Science Hub
The Global Life Science Hub offers functional services and consulting, driven by a solid mission to accelerate, strengthen, and enhance global clinical trials.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase