Marketing Authorization Expert

3 days ago


Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full time

We are seeking a highly experienced Marketing Authorization Expert to join our LCM Product team at Sandoz International GmbH. In this role, you will be responsible for ensuring the successful marketing authorization of our products across multiple countries and product portfolios.

This role requires close collaboration with cross-functional teams, including Supply Chain/Planning/QA/QC and Global RA teams. You will work closely with these teams to ensure timely submission of products in the Nordics and respond to requests from health authorities.

The ideal candidate will have a strong understanding of regulatory guidelines and procedures, with experience in working with electronic document management systems (EDMS) and regulatory information management systems (RIMS). You will also possess excellent communication skills, both written and verbal.

Responsibilities include:

  1. Ensuring marketing authorization of products
  2. Collaborating with cross-functional teams to ensure timely submission of products
  3. Responding to requests from health authorities
  4. Providing guidance on national and EU legislation

Requirements:

  • University degree in a relevant field (e.g., pharmaceutical or life sciences)
  • 3-6 years of experience in regulatory affairs
  • Strong knowledge of regulatory guidelines and procedures
  • Experience with EDMS and RIMS
  • Excellent communication skills


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