Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. 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. We are looking for a Senior Packaging Regulatory Affairs Specialist to join the Biopharma Regulatory department.
What your responsibilities will be: 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. This documentation includes, but is not limited to, administrative data, technical documentation, database, translations, product specifications, artworks of packaging material, PediGri, etc.
Request from other Grifols departments, affiliates, outside companies or Health Authorities anything that is required for a regulatory submission. This may include, but is not limited to, product samples and reagents, payments, certificates, power of attorney, etc.
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 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.
Who you are: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor's Degree in 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.
You are meticulous and detail-oriented.
You have excellent communication and teamwork skills, as well as initiative and results orientation.
What we offer: It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets.
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