Regulatory Affairs Coordinator

2 tygodni temu


Gdańsk, Pomerania, Polska TN Poland Pełny etat

Position: Regulatory Affairs Coordinator

Working hours: Shifts: 9 AM - 5 PM or 3 PM - 11 PM

Contract of employment: Full-time

Level: Mid / Senior

About your future employer:

Our Client is dedicated to helping the world's leading companies build stronger businesses with operations and offices worldwide. As a global player, it can give you the chance to follow training and development programs of all types, and to explore career opportunities and experiences in other countries and departments.

Responsibilities:

  • Act as the first-level support and guide junior staff in compiling regulatory documentation, ensuring that all quality targets are met and validation errors are resolved.
  • Perform technical quality control of dossier documents and complex submissions to ensure compliance with both internal and external standards.
  • Collaborate with relevant stakeholders during the preparation and quality control of reports and regulatory documentation.
  • Provide additional support for other regulatory-related activities as needed by the business.

Essential Skills and Qualifications:

  • Previous experience in electronic submission publishing, dossier management, and the dispatch of regulatory dossiers across various regions.
  • Demonstrated experience in publishing complex and major submissions, including modules 3, 4, and 5.
  • Strong knowledge of global regulatory processes within the pharmaceutical industry and submission publishing requirements.
  • Proficiency with electronic document management systems and publishing tools, along with a deep understanding of document publishing.
  • Excellent verbal and written communication skills.
  • High level of organizational awareness and attention to detail.
  • Advanced level of English.

We offer:

  • Comprehensive training to ensure success in your role
  • Technical or managerial career path (everyone can develop their leadership skills)
  • Be a part of a truly awesome team in a well-located office in Gdańsk
  • Opportunity for professional development in an international environment and for increasing your abilities and skills in various areas
  • Life insurance
  • Private medical care
  • Great atmosphere and comfortable working conditions
  • Stable job and cooperation with a friendly and highly qualified team
  • Hybrid model of work
  • International team and non-corporate work environment

Recruitment process:

  • Short interview with Antal Consultant
  • Interview with HR & Hiring Manager
  • Employment
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