Senior Director, Global Regulatory Lead

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.
• Anticipate risks and devise solutions, understanding the likelihood of technical success for proposed strategies.
• Lead the Global Regulatory Team, fostering a high-performance culture through coaching and mentoring.
• Collaborate with regional regulatory leads and vendors to ensure compliance with local regulations for global submissions.
• Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees.
• Identify regulatory risks and opportunities, developing strategies to mitigate risks and enhance success rates.
• Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) while maintaining compliance with regional and global requirements.
• Act as the primary contact with global health authorities and lead FDA meetings.
• Monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• A 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.
• Experience developing oncology therapeutics is strongly preferred.
• Has a comprehensive and disciplined approach to regulatory risk management and compliance through deep expertise and understanding of the oncology therapeutic area.
• Highly collaborative self-starter and team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• 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; manage multiple projects and timelines simultaneously, and rapidly change priorities based on business needs.

Pay

Washington State Pay Range: $226,000 - $270,000 USD

EEO

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.