Senior Packaging Regulatory Affairs Specialist
hace 1 día
Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909.
We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Job SummaryWe are looking for a Senior Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department.
Key Responsibilities- Prepare, review, follow up, communicate and archive documentation generated at the Regulatory Affairs department or needed for a regulatory submission, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Request from other Grifols departments, affiliates, outside companies or Health Authorities anything that is required for a regulatory submission.
- Maintain regulatory record filing systems for Regulatory Affairs in both hard copy and electronic filing formats, process incoming and outgoing correspondence.
- Represent the regulatory function on project teams for specified documentation generated at Regulatory Affairs department.
- Support to other Departments, affiliates and outside companies in any required information for specified documentation generated at Regulatory Affairs department.
- Create and maintain regulatory affairs working practices and standard operating procedures.
- Assist Regulatory Affairs Specialists to meet business objectives.
- Bachelor's Degree in Life Sciences field is preferred.
- Minimum 2 years of experience in a similar role within pharma industry (RRAA, Documentation, Packaging).
- Advanced level of English.
- User of Microsoft Office tools.
It is a brilliant opportunity for you to join a company that values its employees and provides an excellent working environment.
We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers.
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