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.
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries and a growing global team of over 20,000 people. That's why we need a Regulatory Affairs Specialist like you.
ResponsibilitiesThe Regulatory Affairs Specialist will be responsible for the preparation of technical documentation, submission, and follow-up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation. Your responsibilities will include:
Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.Prepare technical documentation based on the R&D inputs.Coordinate the preparation of the documents needed for regulatory submissions with R&D, manufacturing, and QA departments.Define the regulatory requirements for the products.Prepare and send official responses to any Health Authority questions.Review and assess regulatory impact for product or manufacturing changes.Adapt licenses to current regulations.Manage/coordinate the delivery of product samples or labels related to product registration/renewal/change processes.Revise, approve, and/or coordinate packaging material.Write and manage SOPs.Review technical documents to ensure coherence and compliance with regulatory requirements.Who You AreTo 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:
Bachelor's Degree in Health Sciences or Engineering.Experience in R&D or technical departments.Experience in immunohematology is highly desirable.Advanced level of Spanish and English (C1) and of MS Office (Excel).Analytical skills, attention to detail, and ability to summarize and evaluate.What We OfferIt's a brilliant opportunity for someone with the right talents. Grifols understands you want a challenging and rewarding career in a critical function such as Regulatory Affairs. We'll help you grow professionally.
Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package. Contract of Employment: Permanent position. Location: Parets del Vallès.
We look forward to receiving your application. Grifols is an equal opportunity employer.
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