Regulatory Affairs Specialist
4 days ago
Sant Cugat del Vallès
ph3About the company /h3 pWe believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. /p h3Mission /h3 pThe RRAA Specialist will be responsible of the preparation of technical documentation, submission and following up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation. /p h3What your responsibilities will be /h3 ul liPrepare, compile, and maintain registration dossiers and other regulatory documentation for medicinal products and medical devices within the assigned portfolio. /li liPrepare, review, and submit regulatory documentation for new registrations, renewals, variations, and other regulatory procedures. /li liReview and validate dossiers prepared by other team members, ensuring accuracy, quality, and regulatory compliance. /li liMonitor the progress of regulatory submissions and registration procedures, liaising with regulatory authorities when required. /li liMaintain up-to-date knowledge of current regulations and regulatory requirements applicable to medicinal products and medical devices, ensuring ongoing compliance. /li liCoordinate the translation of regulatory documentation, ensuring accuracy, consistency, and compliance with local market requirements. /li liCollaborate with cross-functional teams and external partners to ensure timely and high-quality regulatory submissions. /li /ul h3Who you are /h3 pTo 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. /p ul liYou have a Bachelor's Degree in Health Sciences or engineering. /li liYou have experience in RRAA or technical departments within the pharmaceutical industry. /li liYou have analytical skills, attention to detail, and ability to summarize and evaluate. /li liYou have Advanced level of Spanish and English (C1) and of MS Office (Excel). /li /ul h3Flexibility for U Program /h3 pHybrid Model /p h3Flexible schedule /h3 pMonday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time). /p h3Benefits package /h3 pContract of Employment: Permanent position. /p pGrifols is an equal opportunity employer. /p /p #J-18808-Ljbffr