Packaging Regulatory Affairs Specialist
hace 2 días
We are seeking a highly skilled Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department at Grifols.
Key Responsibilities:- Prepare, review, and follow up on documentation generated at the Regulatory Affairs department or needed for a regulatory submission, ensuring timeliness, accuracy, and compliance with regulatory standards.
- Request and obtain necessary information from other Grifols departments, affiliates, outside companies, or Health Authorities for a regulatory submission.
- Maintain regulatory record filing systems for Regulatory Affairs in both hard copy and electronic formats, process incoming and outgoing correspondence, and represent the regulatory function on project teams.
- Support other departments, affiliates, and outside companies in providing necessary information for specified documentation generated at the Regulatory Affairs department.
- Create and maintain regulatory affairs working practices and standard operating procedures, and assist Regulatory Affairs Specialists to meet 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, as well as initiative and results orientation.
Grifols is committed to maintaining an atmosphere that encourages all employees to develop their professional careers in an excellent working environment.
We offer a flexible schedule, a benefits package, and a contract of employment with a permanent position and flexibility for the U Program.
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