Regulatory Affairs Coordinator
2 tygodni temu
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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