Regulatory Affairs Specialist
4 godzin temu
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Antal Sp. z o.o. in Poland.
About the RoleThe successful candidate will be responsible for managing global regulatory submissions, ensuring compliance with regulatory requirements, and maintaining accurate documentation.
Key Responsibilities- Manage global regulatory submissions, including dossier publishing and dispatch
- Ensure compliance with regulatory requirements, including US, EU, Asia, and Latin America
- Develop and maintain regulatory documentation, including procedures and work instructions
- Collaborate with stakeholders to ensure quality control and adherence to document standards
- Provide input and advice on submission processes and regulatory requirements
- Support the development of processes and procedures in the team
- Ensure compliance with KPIs and customer satisfaction index
- Science, computer science, or engineering degree
- More than 1 year of experience in pharmaceutical or medical device industry, with relevant experience in electronic submission publishing and dossier management
- 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 and publishing tools
- Experience in eCTD publishing
- Competitive salary compensation
- Private medical care, including dental care
- Life insurance
- Annual bonus
- Great system of bonuses, including MyBenefit Platform and MultiSport Card
- Additional days off
- Career development opportunities
Check out other interesting jobs on: https://en.antal.pl/candidates
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