Regulatory Affairs Specialist
hace 4 semanas
Job Title: Regulatory Affairs Specialist
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Alk-Abelló A/S. As a Regulatory Affairs Specialist, you will be responsible for handling regulatory CMC documentation of products manufactured at our site in Madrid, for worldwide submissions. You will also be responsible for maintenance activities, local regulatory activities, and handling product information.
Responsibilities:
- Coordination and preparation of submission of CMC documentation for Marketing Authorisation Applications/Variations/Renewals of products manufactured at our site in Madrid.
- Handling national phase of variations/MAA submitted by European procedures for products manufactured at other Alk sites.
- Preparation and submission of documentation to obtain special licenses/import licenses in other countries.
- Reviewing change control requests and submitting corresponding variation applications.
- Writing and adapting SmPCs, PL, labels, and abridged SmPCs for promotional materials.
- Applying for Certificates of Pharmaceutical Products (CPP)/Free Sale Certificates and handling subsequent legalization process.
- Providing regulatory input to the Annual Product Quality Review (APQR).
Requirements:
- Knowledge of the European Regulatory Environment.
- Fluent in English and experience in writing technical/scientific documentation.
- Organized, methodical, and detail-oriented.
- Collaborative and able to work autonomously.
- Problem-solving attitude and goal-oriented.
About Alk-Abelló A/S:
Alk-Abelló A/S is a global company with production sites in Denmark, France, Spain, and the United States. We are a pioneer in allergy immunotherapy and continue to innovate, develop, and market new products and solutions for people with allergy.
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