Senior Director, Regulatory Affairs

About the role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Lead global regulatory strategies for assigned products through all phases
• Support Regulatory Affairs for development collaborations and partnerships
• Enhance therapeutic area knowledge and develop tumor landscape assessments
• Advise on laws, regulations, and guidelines affecting product development
• Possibly lead the Labeling Regulatory Team for specified products
• Ensure corporate goals are met for assigned projects
• Provide coaching and mentoring to other regulatory team members

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred
• 10+ years of experience in pharmaceutical regulatory activities
• Experience as lead regulatory product strategist in multiple major regions
• Direct involvement with marketing/license applications like BLA and NDA
• 5+ years in a strategic leadership role with project management skills
• Cross-functional collaboration experience with multiple stakeholders
• Strong communication and negotiation skills

Benefits

• Opportunity to participate in professional associations and industry groups
• Collaborative and fast-paced work environment
• Potential for leadership positions within teams
• Exposure to diverse regulatory environments and practices

Pay

$203,000 – $253,000 annually