Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines

CSL Seqirus

Summit, NJ, United States
Base: $154,000 to $182,000; bonus/equity: incentiv...
Not specified
7 years biotech or pharmaceutical industry experience
5 years regulatory experience required
3 years developmental product experience
CSL Seqirus is seeking a Senior Manager, Regional Regulatory Lead for North America to contribute to regulatory strategies for vaccines. The role requires extensive regulatory experience, particularly with FDA and Health Canada, and focuses on fostering effective relationships to ensure timely regulatory outcomes

Job Summary

  • The role serves as a regulatory leader leveraging North American expertise to drive innovative global strategies for Seqirus vaccines.
  • Responsibilities include ensuring alignment with health authorities like the FDA and Health Canada while leading document preparation and filing activities.
  • CSL Seqirus offers a culture of inclusion and belonging that fuels innovation and connects diverse stakeholders to patient needs.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Senior Manager, Regional Regulatory Lead for North America to contribute to regulatory strategies for vaccines. The role requires extensive regulatory experience, particularly with FDA and Health Canada, and focuses on fostering effective relationships to ensure timely regulatory outcomes.

Salary

Base: $154,000 to $182,000; Bonus/Equity: Incentive compensation included; Benefits: Comprehensive CSL benefits package available

Skills & Requirements

Must-have

  • 7 years biotech or pharmaceutical industry experience
  • 5 years regulatory experience required
  • 3 years developmental product experience
  • Direct interaction with FDA or Health Canada
  • Bachelor's degree in life science field

Nice-to-have

  • Advanced degree in pharmacy or biology preferred
  • Experience in complex matrix environment
  • MBA or advanced clinical degree preferred
  • Strong relationship building skills
  • Patient centric focus approach

Key Requirements

  • Minimum 7 years industry experience
  • Minimum 5 years regulatory experience
  • Minimum 3 years developmental product work
  • Bachelor's degree in life sciences
  • North America regulatory knowledge

Work Rights

Not specified

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