Regulatory Affairs Specialist
hace 3 semanas
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.
- 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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