Regulatory Affairs Manager Alpine

GALDERMA AUSTRALIA

Wien, Austria
Base: 41.804 eur py including 14th salary; bonus/e...
Hybrid
Regulatory programs, processes, and policies
Biologicals, arzneimittel, medizinprodukte, kosmetika
National and international health authority requirements
You will be responsible for the implementation and further development of regulatory programs, processes, and policies for new and existing products in the fields of Biologicals, Pharmaceuticals, Medical Devices, and Cosmetics

Job Summary

  • You will be responsible for the implementation and further development of regulatory programs, processes, and policies for new and existing products in the fields of Biologicals, Pharmaceuticals, Medical Devices, and Cosmetics.
  • You will independently work in a defined area of responsibility for Switzerland and Austria, coordinate regulatory tasks with internal interfaces, and contribute to ensuring compliance through well-founded analyses and structured documentation.
  • We are committed to diversity and inclusion, believing we achieve better results by reflecting the perspectives of our diverse customer base.

Matching Summary

You will be responsible for the implementation and further development of regulatory programs, processes, and policies for new and existing products in the fields of Biologicals, Pharmaceuticals, Medical Devices, and Cosmetics.

Salary

Base: 41.804 EUR per year including 14th salary; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Regulatory programs, processes, and policies
  • Biologicals, Arzneimittel, Medizinprodukte, Kosmetika
  • National and international health authority requirements
  • Switzerland and Austria regulatory responsibility
  • Regulatory dossier management and archiving
  • Life-cycle management and CMC topics

Nice-to-have

  • Passion for meaningful impact
  • Embrace learning and positive energy
  • Teamwork and collaboration
  • Drive dermatology forward
  • French and Italian language skills

Key Requirements

  • Scientific or medical degree or comparable qualification
  • Several years of professional experience in Regulatory Affairs
  • Sound knowledge of regulatory requirements
  • Experience in creating regulatory dossiers
  • Very good knowledge of relevant legal requirements
  • Structured, analytical, and independent working style
  • Very good German and English skills

Work Rights

Not specified

Tailored Resume

Cover Letter