Regulatory Affairs Specialist

6 dni temu


Warszawa, Mazovia, Polska Randstad Polska Pełny etat

Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of the team, you will be responsible for coordinating lifecycle management procedures, ensuring timely submission of high-quality dossiers, and managing validation issues.

Key Responsibilities:

  • Coordinate lifecycle management procedures in-scope of the team and other regulatory procedures
  • Ensure timely submission of high-quality dossiers
  • Manage validation issues and prepare response documents
  • Perform all country-specific activities as described in the country requirements database
  • Perform all lifecycle management activities by following department's processes

Requirements:

  • A minimum of a University degree or equivalent by experience
  • At least 3 years of regulatory affairs experience
  • In-depth knowledge of local and regional regulations/legislation
  • Experience in regulatory lifecycle management and in co-operation with HAs

What We Offer:

  • Employment contract for 12 months with the possibility of extension
  • Hybrid work (2 days a week remote work)
  • Benefits package: medical care, multisport card, life insurance
  • Work in an international environment


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