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Medical Affairs Professional
1 tydzień temu
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 ManagerThis 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.