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

Century Center

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
** The Senior Manager, Regional Regulatory Lead for North America at Seqirus Vaccines is a pivotal role focusing on regulatory strategy and compliance in the biotech and pharmaceutical sectors. The position requires extensive experience in regulatory affairs, particularly with the FDA and Health Canada, and emphasizes building strong relationships with health authorities to ensure successful product outcomes. **

Job Summary

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

Matching Summary

Match Score: 75

** The Senior Manager, Regional Regulatory Lead for North America at Seqirus Vaccines is a pivotal role focusing on regulatory strategy and compliance in the biotech and pharmaceutical sectors. The position requires extensive experience in regulatory affairs, particularly with the FDA and Health Canada, and emphasizes building strong relationships with health authorities to ensure successful product outcomes. **

Salary

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

Skills & Requirements

Must-have

  • 7 years biotech or pharmaceutical industry 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 preferred (MS, PhD, MD)
  • MBA preferred
  • Leadership negotiation skills
  • Strategic risk-taking ability

Key Requirements

  • Bachelor's degree in life science required
  • Minimum 7 years industry experience
  • Minimum 5 years regulatory experience
  • Minimum 3 years on developmental products
  • Direct health authority interaction experience

Work Rights

Not specified

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