Pharmaceutical Compliance Specialist

2 dni temu


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

We are an ambassador for medical product market entry, focused on Central and Eastern Europe and the Middle East. Our mission is to enhance patient access to medicines, medical devices, and dietary supplements by addressing shortages and unmet medical needs.

Job Overview

This role involves coordinating document packages, ensuring compliance, and supporting regulatory strategies for the operational delivery of regulatory documentation for product registration and pharmacovigilance.

Responsibilities
  • Regulatory Submissions: Prepare and maintain regulatory submissions, focusing on the EU market (Poland preferred).
  • Stakeholder Collaboration: Liaise with regulatory therapeutic areas, functional representatives, and key stakeholders to obtain required information.
  • Dossier Management: Oversee dossier plans and submission packages in alignment with regulatory strategies.
  • Pharmacovigilance: Maintain the pharmacovigilance system for our clients, ensuring compliance with safety regulations.
  • Regulatory Standards: Apply appropriate reporting standards to meet health agency requirements.
Requirements
  • Education: University degree in Life Sciences, Pharmacy, or a related field.
  • Experience: Proven experience in regulatory affairs within the pharmaceutical industry.
  • Language Skills: Fluency in English is required; Polish is a plus.
  • Project Management: Strong understanding of Regulatory Information Systems, planning, and publishing tools.
  • Communication Skills: Excellent verbal and written communication skills.


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