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Strategic Regulatory Expert Regional Implementation

1 tydzień temu

Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

Job Overview

We are looking for an experienced Senior Regulatory Affairs Professional to join our team and support the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle.

This role involves closely collaborating with global and regional teams to effectively execute regulatory submission plans, support product approvals, and ensure compliance with local and regional regulatory requirements.

  • Key responsibilities include implementing regional regulatory strategies in alignment with R&D and global regulatory objectives.
  • Collaborating with global and regional teams, including Global Regulatory Teams, Submission Teams, Labeling Working Groups, CTA Working Groups, and clinical teams.

Responsibilities

  • Providing regulatory guidance on regional and local requirements, including the impact of supply chain decisions on registrations.
  • Leading Regional Working Groups to ensure timely execution of regulatory objectives and alignment with global teams.
  • Supporting and communicating regional regulatory activities, ensuring effective coordination between global and local regulatory teams.

Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, or a related field.
  • Minimum of 6 years of industry experience, including at least 3 years in Regulatory Affairs.
  • Broad experience in global drug development and commercialized products.

Desirable Skills

  • Strong ability to manage multiple projects independently in a matrix environment.
  • Excellent verbal and written communication skills in English.
  • Ability to work flexible hours to accommodate meetings across different time zones.