Regulatory Affairs Specialist

hace 3 semanas


Madrid, Madrid, España Alk-Abelló AS A tiempo completo
Regulatory Professional

We are seeking a highly skilled Regulatory Professional to join our team at Alk-Abelló A/S. As a world leader in allergy, our aspiration is to provide options for prevention, diagnosis, and treatment of allergy, helping as many people as possible to a better life.

Key Responsibilities
  • Handling regulatory CMC documentation for products manufactured at our site in Madrid, for worldwide submissions (MAA, Variations, Renewals).
  • Maintenance activities (CMC variations) for products manufactured at our site in Madrid and registered worldwide.
  • Local regulatory activities for products registered in Spain.
  • Handling product information (SmPCs, leaflets, labels).
  • Regulatory surveillance & regulatory support to other functional areas.
Requirements
  • 3 years of experience as a Regulatory Affairs Professional in a pharmaceutical company, preferably multinational.
  • Experience in international projects will be an asset.
  • Bachelor of Science / Master of Science in the Health Science field (e.g. Pharmacy, Biology, etc.).
  • Master's Degree in the Pharmaceutical Industry is strongly recommended.
  • Specific regulatory affairs courses strongly recommended.

As a Regulatory Professional at Alk-Abelló A/S, you will be responsible for coordinating, preparing, and submitting CMC documentation for Marketing Authorisation Applications / Variations / Renewals of products manufactured at our site in Madrid. You will also handle the national phase of variations/MAA submitted by European procedures for products manufactured at other ALK sites.

We are looking for a highly skilled and experienced Regulatory Professional to join our team. If you have a strong background in regulatory affairs and a passion for helping people, we encourage you to apply for this exciting opportunity.



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