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Immunome, Inc. · 2 months ago

Senior Director, Global Regulatory Lead

Bothell, Washington, United States

Full-time

Onsite

Director/Executive

$226K/yr - $270K/yr

10+ years exp

Immunome is a clinical-stage targeted oncology company committed to developing innovative therapies for cancer patients. The Global Regulatory Lead will be responsible for the development and execution of global regulatory strategies, ensuring compliance and driving the regulatory success of products in development throughout their life cycle.

BiopharmaBiotechnologyMedicalPharmaceutical

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

Qualification

Global regulatory strategyRegulatory submissions leadershipOncology therapeutics experienceRegulatory risk managementFDAEMA knowledgeStakeholder communicationAnalytical skillsTeam leadershipOrganizational skillsTime management

Required

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

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

Preferred

Experience developing oncology therapeutics is strongly preferred

Company

Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

Founded in 2008

Exton, Pennsylvania, USA

51-200 employees