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Packaging Regulatory Affairs Specialist
hace 2 meses
Grifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 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 seeking a Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department. This role will be responsible for preparing, reviewing, and communicating documentation generated at the Regulatory Affairs department or needed for a regulatory submission.
Key Responsibilities- Prepare and review documentation, including administrative data, technical documentation, database translations, product specifications, and packaging material artworks.
- Request product samples, reagents, payments, certificates, and power of attorney from other Grifols departments, affiliates, or outside companies.
- Maintain regulatory record filing systems in both hard copy and electronic formats.
- Represent the regulatory function on project teams for specified documentation.
- Support other departments, affiliates, and outside companies with required information for specified documentation.
- Create and maintain regulatory affairs working practices and standard operating procedures.
- Assist Regulatory Affairs Specialists to meet business objectives.
To perform this job successfully, an individual must have a Bachelor's Degree in a Life Sciences field and a minimum of 2 years of experience in a similar role within the pharma industry. Advanced English language skills and proficiency in Microsoft Office tools are also required.
The ideal candidate will be meticulous, detail-oriented, and have excellent communication and teamwork skills, as well as initiative and results orientation.What We Offer
Grifols offers a brilliant opportunity for professional growth and development in an excellent working environment. We provide a flexible schedule, a benefits package, and a permanent contract of employment. The location of this position is in Sant Cugat del Vallès, Spain.
