Developing antibody-based therapeutics by unlocking the human memory B cell response.
Senior Director, Global Regulatory Lead
Location
United States
Posted
104 days ago
Salary
$226K - $270K / year
Seniority
Senior
Job Description
Senior Director, Global Regulatory Lead
Immunome, Inc.
• Define and implement global regulatory strategies that adapt to changing regulatory and business needs. • Communicate key developments to project teams and stakeholders, ensuring alignment and sound judgment. • Lead the Global Regulatory Team, fostering a high-performance culture through coaching and mentoring. • Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees. • Ensure timely preparation and submission of regulatory submissions while maintaining compliance with regional and global requirements. • Monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development.
Job Requirements
- Bachelor’s degree in a relevant scientific discipline.
- A minimum of 10 years experience in global regulatory affairs in the pharmaceutical/biotechnology industry.
- Proven success in leading regulatory submissions and obtaining approvals in major markets.
- Experience developing oncology therapeutics is strongly preferred
Benefits
- Health insurance
- 401(k) matching
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