Regulatory Compliance Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full time

We are seeking a highly skilled Regulatory Compliance Specialist to join our Life Cycle Management (LCM) Product team at Sandoz International GmbH. As a key member of our team, you will be responsible for ensuring the regulatory compliance of marketing authorizations across multiple countries and product portfolios.

This role requires close collaboration with Supply Chain/Planning/QA/QC as well as Global RA teams. You will work closely with cross-functional teams to ensure timely submission of products in the Nordics and respond to requests from health authorities. Additionally, you will act as an expert, providing guidance on national and EU legislation within the regulatory field.

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 regulatory compliance of marketing authorization
  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)
  • 1-5 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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