Regulatory Affairs Specialist

1 dzień temu


Gdańsk, Pomerania, Polska Antal Sp. z o.o. Pełny etat
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Antal Sp. z o.o. in Gdałsk. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and providing support to our clients in the pharmaceutical industry.

Key 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.
Requirements
  • 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.
What 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 Gdałsk
  • Opportunity for professional development in an international environment and for increasing your abilities and skills in various areas
  • Life insurance
  • Private medical care
  • Flexible working hours
  • Great atmosphere and comfortable working conditions
  • Stable job and cooperation with friendly and high-qualified team
  • Soft skills development
  • Hybrid model of work
  • Integration events
  • International team and non-corporate work environment
Recruitment Process
  1. Short interview with Antal Consultant
  2. Interview with HR & Hiring Manager
  3. Employment


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