Regulatory Affairs Expert
1 tydzień temu
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Antal Sp. z o.o.
The ideal candidate will have a strong background in pharmaceutical regulations and experience with electronic submission publishing, dossier management, and dispatch of regulatory dossiers.
Key Responsibilities:- Compile and maintain regulatory documentation as per procedure in client repository
- Perform high-level file formatting using client-provided software
- Ensure technical quality control of dossier documents adhering to internal and external document standards
- Interact with stakeholders during preparation and quality control of reports and regulatory documentation
- Provide input and advice on relevant aspects of the submission process
- Support clients in aligning process maps/SOPs/WI as per recent updates
- Participate in regulatory-related activities as per business requirements
- Ensure training and compliance with applicable CTS and BI "Quality Management System"
- Science, computer science, or engineering degree
- More than 1 year of experience in pharmaceutical/medical device/related industry with relevant experience in electronic submission publishing, dossier management, and dispatch of regulatory dossiers (US, EU, Asia, Latin America, etc)
- Expertise in submission publishing requirements globally
- Strong knowledge of regulatory processes
- Excellent verbal and written communication skills
- Demonstrated ability to be innovative and a creative thinker
- High level of organizational awareness
- Experience with electronic document management systems, publishing tools, knowledge of documents publishing/document management
- Experience in eCTD publishing
- Competitive salary compensation
- Private medical care, including dental care
- Life insurance
- Annual bonus
- Great system of bonuses, including MyBenefit Platform, MultiSport Card, Holiday subsidy
- Additional days off
- Career development opportunities
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