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2 dni temu
We are seeking a highly skilled Regulatory Affairs Manager to oversee the operational delivery of regulatory documentation for product registration and pharmacovigilance.
Main Responsibilities- Regulatory Submissions: Coordinate the preparation and maintenance of 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.
- 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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