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

CSL SEQIRUS

Summit, NJ, USA
Base: $154,000 to $182,000; bonus/equity: incentiv...
Not specified (likely hybrid based on industry norms)
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 CSL Seqirus is responsible for leading regulatory strategies and engagements with health authorities like the FDA and Health Canada. The role demands a strong background in regulatory affairs within the biotech or pharmaceutical industry, emphasizing collaboration and leadership within a global regulatory framework

Job Summary

  • The role serves as a regulatory leader leveraging North America expertise to drive innovative global strategies for Seqirus Vaccines.
  • Candidates will partner with Global Regulatory Affairs Strategy Team members to ensure appropriate inputs into risk assessment and decision making.
  • The position offers an opportunity to lead assigned negotiations with health authorities like the FDA and Health Canada to achieve desired regulatory outcomes.

Matching Summary

Match Score: 85

The Senior Manager, Regional Regulatory Lead for North America at CSL Seqirus is responsible for leading regulatory strategies and engagements with health authorities like the FDA and Health Canada. The role demands a strong background in regulatory affairs within the biotech or pharmaceutical industry, emphasizing collaboration and leadership within a global regulatory framework.

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 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)
  • Leadership capabilities application
  • Patient centric-focus approach

Key Requirements

  • Bachelor's degree in life science required
  • Minimum 7 years industry experience
  • Minimum 5 years regulatory experience
  • Minimum 3 years developmental product experience
  • Direct interaction with FDA or Health Canada

Work Rights

Not specified

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