Executive Director, Global Regulatory Portfolio Lead

Responsibilities

• Develop and implement global regulatory strategies for product development and market access
• Lead regulatory aspects for products through all phases of development and post-approval life-cycle
• Oversee preparation of regulatory documents ensuring compliance and timely submissions
• Negotiate with global regulatory authorities on key development issues
• Monitor global regulatory environment for impacts on business product development
• Train and manage a regulatory team, fostering development and performance
• Build partnerships with internal stakeholders to align regulatory strategies with business objectives

Qualifications

• BA/BS Degree with 14+ years in biopharmaceutical industry, or MA/MS/MBA with 10+ years in Regulatory affairs
• Experience as a lead in Regulatory Affairs across multiple major geographies, with a background in both small molecules and biologics
• Deep understanding of drug development processes, regulatory requirements, and healthcare trends
• Expertise in developing and executing global regulatory strategies with a proven track record in INDs, NDAs, and lifecycle management
• Strong business acumen with the ability to make decisions beneficial to corporate objectives
• Creative strategic skills to navigate challenges in the regulatory environment

Benefits

• Comprehensive medical, dental, and vision plans
• 401(k) plan with company match
• Flexible spending accounts (FSA/HSA)
• Life insurance coverage
• Generous paid time off policy
• Wellness programs and initiatives
• Opportunity for employee stock ownership through equity awards

Pay

$284,700 – $364,700 annually

Schedule

Remote - US based candidates only, no visa sponsorship available