Senior Director/Executive Director, Global Regulatory Lead

The role

The Global Regulatory Lead will develop and execute global regulatory strategies for a therapeutic portfolio. This person will lead the Global Regulatory Team and act as the primary contact with global health authorities.

What you will do

• Define and implement global regulatory strategies
• Communicate key developments to project teams and stakeholders
• Anticipate risks and devise solutions
• Lead the Global Regulatory Team through coaching and mentoring
• Collaborate with regional regulatory leads and vendors
• Advocate for regulatory positions in governance and cross-functional committees
• Identify regulatory risks and opportunities
• Ensure timely preparation and submission of regulatory submissions
• Act as the primary contact with global health authorities and lead FDA meetings
• Monitor industry trends and regulatory changes

Required qualifications

• Bachelor’s degree in relevant scientific discipline
• Minimum of 10 years of experience in global regulatory affairs in the pharmaceutical / biotechnology industry, or equivalent experience
• Proven success in leading regulatory submissions and obtaining approvals in major markets
• Direct experience leading regulatory submissions, health authority meetings and interactions
• In-depth knowledge of the internal operations and outlook of the FDA, EMA and other global health authorities
• Comprehensive and disciplined approach to regulatory risk management and compliance
• Deep expertise and understanding of the oncology therapeutic area
• Highly collaborative self-starter and team player
• Outstanding communication, analytical, organizational and time management skills
• Experience and passion to work with small teams
• Ability to work comfortably under pressure under evolving scenarios and tight deadlines
• Detail-minded yet flexible work style

Nice to have

• Experience developing oncology therapeutics is strongly preferred

Benefits

• Medical, dental, and vision insurance coverage for employees and their dependents
• 100% company-paid medical premiums for employees
• 401(k) with employer match
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D
• Paid time off
• Company holidays
• A week-long winter break between Christmas and New Years
• Paid parental leave

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics including antibody-drug conjugates.