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

CSL Seqirus

Holly Springs, NC, USA
Base: $154,000 to $182,000; bonus/equity: incentiv...
Hybrid
7 years biotech or pharmaceutical experience
5 years regulatory experience required
3 years developmental product experience
The role serves as a regulatory leader leveraging North America expertise to drive innovative global strategies for assigned vaccine products

Job Summary

  • The role serves as a regulatory leader leveraging North America expertise to drive innovative global strategies for assigned vaccine products.
  • Candidates will actively partner with health authorities like the FDA and Health Canada to ensure timely delivery of successful regulatory outcomes.
  • This hybrid position requires onsite presence three days a week at locations in Holly Springs NC, Summit NJ, Waltham MA, or Quebec Canada.

Matching Summary

The role serves as a regulatory leader leveraging North America expertise to drive innovative global strategies for assigned vaccine products.

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Experience in complex matrix environment
  • Advanced degree in life sciences or MBA
  • Patient centric focus approach
  • Strategic risk-taking capability
  • Strong cross-functional partnership skills

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
  • Minimum 7 years industry experience with 5 years in regulatory affairs
  • Direct interaction experience with FDA or Health Canada
  • Understanding of regulatory filing pathways for North America region

Work Rights

Not specified

Tailored Resume

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