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Medical Affairs Professional

1 tydzień temu

Warszawa, Mazovia, Polska OtiPharm Alliance Pełny etat
About Our Company

We are a specialist in medical product market entry, with a strong presence in Central and Eastern Europe and the Middle East.

Job Title: Regulatory Affairs Manager

This role involves managing the operational delivery of regulatory documentation for product registration and pharmacovigilance within the EU market, with a focus on Poland.

Your Key Responsibilities:

  • Manage the preparation and maintenance of regulatory submissions, with a focus on EU market requirements.
  • Liaise with stakeholders to obtain necessary information for regulatory submissions.
  • Develop and maintain dossier plans and submission packages in alignment with regulatory strategies.
  • Ensure the pharmacovigilance system for clients is compliant with safety regulations.
  • Apply relevant reporting standards to meet health agency requirements.

Required Skills and Qualifications:

  • University degree in Life Sciences, Pharmacy, or a related field.
  • Proven experience in regulatory affairs within the pharmaceutical industry.
  • Fluent English language skills; Polish is an asset.
  • Strong understanding of Regulatory Information Systems, planning, and publishing tools.
  • Excellent communication and interpersonal skills.

What We Offer:

  • A challenging full-time position with opportunities for career advancement.
  • A modern office location in Warsaw.
  • Performance-based bonuses.