Regulatory Affairs Specialist
1 dzień temu
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.
- 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.
- 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
- Short interview with Antal Consultant
- Interview with HR & Hiring Manager
- Employment
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