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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 we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.
Job SummaryWe are seeking a highly skilled Senior Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department. As a key member of our team, you will be responsible for preparing, reviewing, and communicating regulatory documentation to ensure compliance with regulatory standards.
Key Responsibilities- Regulatory Documentation Management: Prepare, review, and follow up on documentation generated at the Regulatory Affairs department or needed for a regulatory submission, ensuring timeliness, accuracy, and comprehensiveness.
- Documentation Requests: Request necessary documentation from other Grifols departments, affiliates, outside companies, or health authorities to support regulatory submissions.
- Regulatory Record Filing: Maintain regulatory record filing systems for Regulatory Affairs in both hard copy and electronic formats, process incoming and outgoing correspondence.
- Project Team Representation: Represent the regulatory function on project teams for specified documentation generated at the Regulatory Affairs department.
- Regulatory Affairs Support: Support other departments, affiliates, and outside companies in providing required information for specified documentation generated at the Regulatory Affairs department.
- Regulatory Affairs Working Practices: Create and maintain regulatory affairs working practices and standard operating procedures.
- Business Objectives Support: Assist Regulatory Affairs Specialists to meet business objectives.
- Education: Bachelor's Degree in a Life Sciences field is preferred.
- Experience: Minimum 2 years of experience in a similar role within the pharma industry (RRAA, Documentation, Packaging).
- Language Skills: Advanced level of English.
- Technical Skills: User of Microsoft Office tools.
- Personal Qualities: Meticulous and detail-oriented, excellent communication and teamwork skills, 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 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.
