Regulatory Affairs Specialist

4 godzin temu


Gdańsk, Pomerania, Polska Antal Sp. z o.o. Pełny etat
Senior Regulatory Affairs Specialist

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Antal Sp. z o.o. in Poland.

About the Role

The 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
Requirements
  • 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
What We Offer
  • 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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