Immunome, Inc. logo
Immunome, Inc.

Developing antibody-based therapeutics by unlocking the human memory B cell response.

Senior Director, Global Regulatory Lead

ComplianceComplianceFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

11 days ago

Salary

$226K - $270K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

• 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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