Regulatory Affairs Manager

4 dni temu


Warszawa, Mazovia, Polska OtiPharm Alliance Pełny etat

OtiPharm Alliance is an ambassador for medical product market entry, with a strong focus 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.

We are looking for a Regulatory Affairs Manager to oversee the operational delivery of regulatory documentation for product registration and pharmacovigilance. This role involves coordinating document packages, ensuring compliance, and supporting regulatory strategies.

Your 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.
What We Expect From You:
  • 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.
What We Offer:
  • Full-time Position with career growth opportunities.
  • Office Location: Modern business center in Warsaw.
  • Performance-Based Bonuses.

Join us and be part of a team that makes a real impact on global healthcare access Apply now Send your CV to l.torhun@otipharm.com with the subject Regulatory Affairs

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Pharmaceutical Manufacturing

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