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5 dni temu
OtiPharm Alliance is a leading ambassador for medical product market entry, focusing 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.
Key Responsibilities- Regulatory Submissions: Coordinate the preparation and maintenance of regulatory submissions, with a focus 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.
- 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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