Regulatory Affairs Officer

Teva Pharmaceuticals

📍 Porto Salvo, Lisbon, Portugal

Full-time Business Operations Specialists

Job Description

The opportunity

We are looking for a Regulatory Affairs Associate/Officer to join us in Teva Porto-Salvo office. We have a hybrid approach to home-working!

You mission will be to coordinate and prepare applications for registration, variations, revalidations and pricing to obtain approvals from the Portuguese and European regulatory authorities, ensuring that the appropriate processes for the registration, launch and maintenance of our products are complied with in a timely manner and that safety and quality control standards are met.

How you’ll spend your day

  • New Registration Applications (National/MRP/DCP/CP) Preparation of registration file and requirements within the established deadlines
    Follow-up of registration, deficiency letters, allegations and responses to authorities, agree final texts with INFARMED to obtain marketing authorization.
    Artworks: elaboration, review and approval of artworks for new r...
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