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Packaging Regulatory Affairs Specialist
hace 2 meses
Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. With a rich history dating back to 1909, we have established ourselves as leaders in plasma-derived medicines and transfusion medicine.
Job SummaryWe are seeking a highly skilled Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department. As a key member of our team, you will play a crucial role in ensuring the compliance of our packaging materials with regulatory standards.
Key Responsibilities- Prepare, review, and archive documentation related to regulatory submissions, ensuring accuracy, comprehensiveness, and compliance with regulatory standards.
- Request necessary documentation and materials from internal and external sources, including product samples and reagents.
- Maintain regulatory record filing systems and process incoming and outgoing correspondence.
- Represent the regulatory function on project teams and support other departments in regulatory matters.
- Create and maintain regulatory affairs working practices and standard operating procedures.
- Assist Regulatory Affairs Specialists in meeting business objectives.
- Bachelor's Degree in a Life Sciences field is preferred.
- Minimum 2 years of experience in a similar role within the pharma industry (RRAA, Documentation, Packaging).
- Advanced level of English.
- User of Microsoft Office tools.
- Meticulous and detail-oriented with excellent communication and teamwork skills.
Grifols is committed to maintaining an excellent working environment that encourages employee growth and development. We offer a flexible schedule, benefits package, and a permanent position with opportunities for career advancement.
