Position Overview

As the Global Regulatory Lead at Immunome, you will be the key decision-maker responsible for the development and execution of innovative global regulatory strategies for our therapeutic portfolio to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. You will work collaboratively across teams to ensure compliance and alignment with corporate objectives, driving the regulatory success of our products in development and throughout their life cycle. This position will report to the Vice President, Regulatory Affairs.

Responsibilities

Regulatory Strategy Development

• Define and implement global regulatory strategies that adapt to changing regulatory and business needs.

Cross-Functional Leadership

• 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.

Team Leadership

• 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.

Stakeholder Communication

• Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees.

Risk Management

• Identify regulatory risks and opportunities, developing strategies to mitigate risks and enhance success rates.

Regulatory Submission Oversight

• 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.

Continuous Improvement

• Monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development.

Qualifications

• Bachelor’s degree in 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.

Knowledge and Skills

• Direct experience leading regulatory submissions, health authority meetings and interactions with in-depth knowledge of the internal operations and outlook of the FDA, EMA and other global health authorities.
• 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.