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

CSL Seqirus

Summit, NJ, USA
Base: $154,000 to $182,000; bonus/equity: incentiv...
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North america regulatory experience
Fda and health canada interaction
Biotech or pharmaceutical industry background
** CSL Seqirus is seeking a Senior Manager, Regional Regulatory Lead for North America within their Global Regulatory Strategy team. The role requires significant regulatory experience in the biotech or pharmaceutical industry, specifically interacting with health authorities like the FDA and Health Canada, while promoting a culture of teamwork and accountability. **

Job Summary

  • The role serves as a regulatory leader leveraging North America expertise to drive innovative global strategies for Seqirus vaccines with a patient-centric focus.
  • Candidates will partner with global teams to ensure timely delivery of successful regulatory outcomes through active engagement with the FDA and Health Canada.
  • CSL Seqirus offers a culture of inclusion and belonging that fuels innovation while providing state-of-the-art production facilities across the U.S., U.K., and Australia.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a Senior Manager, Regional Regulatory Lead for North America within their Global Regulatory Strategy team. The role requires significant regulatory experience in the biotech or pharmaceutical industry, specifically interacting with health authorities like the FDA and Health Canada, while promoting a culture of teamwork and accountability. **

Salary

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

Skills & Requirements

Must-have

  • North America regulatory experience
  • FDA and Health Canada interaction
  • Biotech or pharmaceutical industry background
  • Developmental product regulatory knowledge
  • Module 1 documentation preparation

Nice-to-have

  • Matrix environment experience
  • Advanced degree in life sciences
  • MBA preferred qualification
  • Patient centric focus approach
  • Prudent risk-taking capability

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related life science
  • Minimum 7 years biotech/pharma experience with 5 years regulatory focus
  • 3 years working on developmental products required
  • Direct experience interacting with FDA or Health Canada
  • Understanding of North American regulatory requirements for biological products

Work Rights

Not specified

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