Global Regulatory Lead

• Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally
• Guide filing strategy and coordinate across disciplines to ensure timely filings
• Oversee regulatory affairs vendors involved in marketing authorization filings
• Help ensure high-quality interactions with regulators
• Contribute hands-on to regulatory filings, including INDs, BLAs, and MAAs
• Provide regulatory leadership for post-approval activities, including drug registration and listing and payment of program user fees
• Monitor, interpret, and communicate changes to the global regulatory landscape
• Serve as regulatory affairs business partner to local commercialization teams
• Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input
• Serve as conduit between assigned project-team strategy and broader global regulatory and development teams

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations
• At least 5–7 years in global leadership roles focused on major regulatory regions such as FDA, EMA, or PMDA
• Thorough understanding of the drug development process
• Expertise in orphan drugs
• Knowledge of developing regulations and guidelines, specifically in the United States
• Demonstrated ability to coordinate critical regulatory documents for medicine approvals, with a focus on the FDA
• Experience interacting with regulatory authorities, especially the FDA and EMA
• Familiarity with current and emerging regulatory legislation, industry trends, and global healthcare business practices
• Highly developed organizational and project management skills
• Strategic planning, delegation, resource allocation, and workload prioritization skills
• Outstanding presentation, written, and verbal communication skills
• Track record of successful interactions with regulatory and health authorities
• Strong leadership ability, including building, motivating, and developing a team
• Ability to operate in a fast-paced, results-driven, highly accountable environment
• Ability to combine strategic thinking with individual and team execution in a matrix environment
• PhD or PharmD preferred
• Prior experience in rapidly growing pharmaceutical organizations desirable

• Fully Remote work mode
• Standard Monday–Friday work schedule