Regulatory Affairs Specialist

4 dni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat
About the Role

The Regulatory Specialist will play a crucial role in supporting operational activities related to the maintenance of marketing authorizations across assigned markets and submission types in European Partnership Markets.

This position requires 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.

Key responsibilities include providing inputs and support to planning and tracking of regulatory activities, managing routine operational steps within RIM systems, and collaborating with global regulatory centers to ensure compliance of regulatory documentation with countries' requirements.

Key Responsibilities
  1. Supporting country leads in activities related to MA maintenance for assigned markets and/or submission types across pharma and vaccines portfolio.
  2. Providing inputs and support to planning and tracking of regulatory activities for defined markets/submission types.
  3. Managing routine operational steps within RIM systems related to local activities within end-to-end regulatory processes, including data assessments.
  4. Collaborating with global regulatory centers (GRC) to support effective management of product registration documents and agency correspondence in RIM systems.
  5. Building and maintaining effective relationships with internal and external stakeholders.
Qualifications
  • Master's/Bachelor's degree in scientific discipline (life sciences/pharmacy/professions aligned to medicine).
  • Approximately 2 years of relevant experience in regulatory affairs and pharmaceutical industry.
  • Understanding of the pharmaceutical industry and regulatory processes related to license maintenance.
  • Awareness of policies and regulatory climate in Europe.
  • Fluent English language skills (speaking and writing).

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