Pharmaceutical Regulatory Expert

2 tygodni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat
Regulatory Affairs Role

The Regulatory Specialist will be responsible for supporting operational activities related to the maintenance of marketing authorizations across assigned markets and submission types in European Partnership Markets.

This role involves close collaboration with country leads, global regulatory teams/centers, and local 3rd party service providers to ensure effective management of product registration documents and agency correspondence within Regulatory Information Management systems.

Main Job Responsibilities
  1. Supporting country leads in activities related to MA maintenance for assigned markets and/or submission types.
  2. Providing input to planning and tracking of regulatory activities for defined markets/submission types.
  3. Collaborating with global regulatory centers to ensure compliance of regulatory documentation with countries' requirements.
  4. Building and maintaining effective relationships with internal and external stakeholders.
Required Skills and Qualifications
  • Relevant Master's/Bachelor's degree in life sciences or related field.
  • At least 2 years of experience in regulatory affairs and pharmaceutical industry.
  • Excellent understanding of regulatory processes and policies in Europe.
  • Strong communication and collaboration skills.


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