Senior Specialist Regulatory Affairs

Abbott

Weesp, Netherlands
Onsite
Regulatory strategy development
Labeling and clinical modules
Ccds and labeling documentation
Drive regulatory strategies and submissions for influenza vaccines across Developed and Emerging Markets

Job Summary

  • Drive regulatory strategies and submissions for influenza vaccines across Developed and Emerging Markets.
  • Define, develop, and maintain pre-clinical, clinical, and labeling strategies for influenza vaccines in line with business objectives.
  • Work at Abbott offers career development, a local benefit package, and recognition as a great place to work.

Matching Summary

Drive regulatory strategies and submissions for influenza vaccines across Developed and Emerging Markets.

Skills & Requirements

Must-have

  • regulatory strategy development
  • labeling and clinical modules
  • CCDS and labeling documentation
  • annual PSURs submission
  • Module I for EU Annual Strain Update

Nice-to-have

  • curious and detail-oriented
  • collaborative team environment
  • navigating complexity with confidence
  • adaptable and open-minded

Key Requirements

  • Bachelor's or Master's degree
  • 3-5 years Regulatory Affairs experience
  • Strong knowledge of medicines registration
  • Excellent communication skills
  • Project management skills

Work Rights

Not specified

Tailored Resume

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