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REGULATORY AFFAIRS & PHARMACOVIGILANCE SPECIALIST

Adamed is a family-owned pharmaceutical and biotechnology company with Polish roots. Our portfolio includes nearly 900 products available in Poland and several dozen other countries around the world. Today, we are an international team of nearly 2,800 employees. For over 20 years, we have been conducting our own innovative research and development activities. Adamed collaborates scientifically with leading universities, medical experts, and research institutes both in Poland and abroad. The company’s intellectual property is protected by more than 200 patents worldwide. Thanks to innovation, courage, and the dedication of our teams, Forbes has recognized us as the best employer in the pharmaceutical and biotechnology industry for the third year in a row.

YOUR MAIN RESPONSIBILITIES

Regulatory Affairs:

  • Manage product registrations, variations, and renewals.
  • Prepare regulatory dossiers and liaise with Health Authorities.
  • Monitor national and international regulations and ensure compliance.
  • Review and approve packaging materials.

Quality Assurance (GDP):

  • Ensure compliance with Good Distribution Practices (GDP).
  • Review batch documentation (CoA, release documentation).
  • Manage quality incidents, CAPAs, and customer complaints.
  • Support audits, self-inspections, and maintenance of the quality system.
  • Oversee proper product transportation and storage conditions.

Pharmacovigilance:

  • Monitor medicinal product safety and ensure GVP compliance.
  • Communicate with Health Authorities and respond to requests.
  • Participate in risk management activities and post-authorisation studies.

WHAT'S MPORTANT TO US

  • Degree in Pharmacy (minimum requirement).
  • Minimum 3 years of experience in the pharmaceutical industry.
  • At least 3 years of experience in Regulatory Affairs.
  • Advanced Excel skills.
  • Fluent English (spoken and written).
  • eCTD sequences experience
  • Experience in QA (QDP) will be an advantage.

Key competencies:

  • Strong knowledge of pharmaceutical regulations.
  • Strategic thinking and high attention to detail.
  • Problem-solving and decision-making skills.

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