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 interactions
Pharmaceutical product development knowledge
** The Senior Manager, Regional Regulatory Lead at CSL Seqirus is responsible for overseeing regulatory strategies and interactions with health authorities in North America, ensuring successful outcomes for vaccine products. The role requires a strong background in regulatory affairs within the biotech or pharmaceutical industry, with an emphasis on experience with developmental products. **

Job Summary

  • The role serves as a regulatory leader leveraging North American expertise to drive innovative, patient-centric global strategies for Seqirus vaccines.
  • Candidates will be accountable for managing relationships with the FDA and Health Canada while ensuring timely delivery of successful regulatory outcomes.
  • CSL Seqirus offers a culture of inclusion and belonging that fuels innovation and connects diverse workforces to better understand patients.

Matching Summary

Match Score: 75

** The Senior Manager, Regional Regulatory Lead at CSL Seqirus is responsible for overseeing regulatory strategies and interactions with health authorities in North America, ensuring successful outcomes for vaccine products. The role requires a strong background in regulatory affairs within the biotech or pharmaceutical industry, with an emphasis on experience with developmental products. **

Salary

Base: $154,000 to $182,000; Bonus/Equity: Incentive compensation included; Benefits: Comprehensive well-being support detailed

Skills & Requirements

Must-have

  • North America regulatory experience
  • FDA and Health Canada interactions
  • Pharmaceutical product development knowledge
  • Module 1 documentation preparation
  • Health authority filing pathways

Nice-to-have

  • Advanced degree in life sciences or MBA
  • Experience in complex matrix environment
  • Patient centric focus approach
  • Strategic risk-taking capabilities
  • Leadership negotiation potential

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field
  • Minimum 7 years biotech/pharma industry experience
  • At least 5 years regulatory experience including 3 years on developmental products
  • Direct interaction experience with FDA or Health Canada
  • Salary range $154,000 to $182,000 base pay

Work Rights

Not specified

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