Aktualne oferty pracy związane z Regulatory Affairs Specialist - Gdańsk, Pomerania - TN Poland
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Training Specialist
3 godzin temu
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Regulatory Affairs Specialist
2 tygodni temu
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at TN Poland. In this role, you will be responsible for global regulatory submission and dossier publishing activities, ensuring seamless delivery of high-quality documents.
Key Responsibilities:
- Submission Publishing: Responsible for day-to-day submission publishing activities and deliverables globally.
- Regulatory Documentation Management: Compile and maintain regulatory documentation in client repositories according to established procedures.
- File Formatting and Optimization: Utilize client-provided software to perform high-level file formatting, creating bookmarks, hyperlinks, and optimizing files for efficient publishing.
- Quality Control: Perform technical quality control of dossier documents to ensure adherence to internal and external document standards.
- Stakeholder Collaboration: Interact with relevant stakeholders during report preparation and quality control of regulatory documentation.
- Process Alignment: Provide input and advice on the submission process, supporting clients in aligning process maps, SOPs, and WI as per recent updates.
- Education: Science, computer science, or engineering degree.
- Experience: More than 1 year of experience in pharmaceutical, medical device, or related industries, with expertise in electronic submission publishing, dossier management, and dispatch of regulatory dossiers (US, EU, Asia, Latin America, etc.).
- Expertise: Strong knowledge of regulatory processes and requirements globally.
- Communication Skills: Excellent verbal and written communication skills.
- Creativity and Innovation: Demonstrated ability to be innovative and creative in problem-solving.
