Senior Director, Global Regulatory Lead
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Job Description
Global Regulatory Lead overseeing regulatory strategies for Immunome's oncology portfolio. Collaborating with teams to ensure compliance and drive product success through innovative regulatory challenges.
Responsibilities:
- 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.
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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