Sr. Regulatory Affairs Specialist - Abbott Nutrition Division

Abbott

Taguig City, Philippines
Dossier preparation and submission
Regulatory agency approvals
Label and packaging development
Prepare a quality regulatory dossier for Food/Nutritional, Drugs, Medical Device products and submit within the planned affiliate timelines

Job Summary

  • Prepare a quality regulatory dossier for Food/Nutritional, Drugs, Medical Device products and submit within the planned affiliate timelines.
  • Gain Food and Drug Administration (FDA) or respective regulatory agency approvals to meet the affiliate product launch plans and ensure product maintenance.
  • Keep abreast of regulatory updates, changes and trends affecting local regulations which could impact business environment and communicate appropriately with affected parties.

Matching Summary

Prepare a quality regulatory dossier for Food/Nutritional, Drugs, Medical Device products and submit within the planned affiliate timelines.

Skills & Requirements

Must-have

  • Dossier preparation and submission
  • Regulatory agency approvals
  • Label and packaging development
  • Compliance maintenance
  • Regulatory updates and trends

Nice-to-have

  • Cross-functional team management
  • Strong communication skills
  • Attention to detail

Key Requirements

  • Minimum 5 years regulatory affairs experience
  • 2 years supervisory/specialist level experience
  • FDA Center for Food regulations knowledge
  • B.S. Food Technology or allied courses

Work Rights

Not specified

Tailored Resume

Cover Letter