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

CSL

Summit, NJ, United States
Base: $154,000 to $182,000; bonus/equity: incentiv...
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7 years biotech or pharmaceutical industry experience
5 years regulatory experience required
3 years developmental product experience
** CSL is seeking a Senior Manager, Regional Regulatory Lead for North America within their Seqirus Vaccines division. The role requires extensive regulatory experience in the biotech or pharmaceutical industry, with a focus on fostering relationships with health authorities like the FDA and Health Canada. **

Job Summary

  • The role involves leveraging North American regulatory expertise to drive innovative, globally integrated strategies for Seqirus vaccines.
  • Candidates will ensure timely delivery of successful regulatory outcomes by maintaining productive relationships with the FDA and Health Canada.
  • CSL offers a culture of inclusion and belonging that fuels innovation and connects the diverse workforce with patients and stakeholders.

Matching Summary

Match Score: 75

** CSL is seeking a Senior Manager, Regional Regulatory Lead for North America within their Seqirus Vaccines division. The role requires extensive regulatory experience in the biotech or pharmaceutical industry, with a focus on fostering relationships with health authorities like the FDA and Health Canada. **

Salary

Base: $154,000 to $182,000; Bonus/Equity: Incentive compensation may be included; Benefits: CSL supports well-being with comprehensive benefits package

Skills & Requirements

Must-have

  • 7 years biotech or pharmaceutical industry experience
  • 5 years regulatory experience required
  • 3 years developmental product experience
  • Direct FDA or Health Canada interaction
  • North America regulatory requirements knowledge

Nice-to-have

  • Experience in complex matrix environment
  • Advanced degree in life sciences or MBA
  • Leadership negotiation skills with health authorities
  • Patient centric focus in strategy
  • Proactive risk-taking approach

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
  • Minimum 7 years total experience in biotech/pharma industry
  • At least 5 years of specific regulatory affairs experience
  • Minimum 3 years working on developmental products
  • Understanding of North American regulatory filing pathways

Work Rights

Not specified

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