Job Description

The Opportunity


Our client is an internationally operating pharmaceutical organization seeking an experienced Regulatory Affairs professional. This position offers broad regulatory responsibilities across the full product lifecycle within a collaborative international environment.


Regulatory Affairs Manager (m/f/d)

Location: Leipzig (in combination with homeoffice)


Aufgaben



  • Drive regulatory submissions across multiple international markets.

  • Prepare high-quality regulatory dossiers and lifecycle applications.

  • Review scientific documentation for submission readiness.

  • Ensure regulatory compliance throughout development activities.

  • Provide regulatory guidance to internal stakeholders.

  • Evaluate regulatory consequences of proposed product changes.

  • Update product labeling and regulatory documentation.

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