Do you want to join an international team working to improve the future of healthcare?
Do you want to improve the lives of millions of people?
Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world.
Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Help to grow one of the world's most innovative companies!
We are looking for a Regulatory Affairs Manager who will be responsible for ensuring compliance with the priority plan, as well as the coordination of compilation, submission, and follow-up of product registration and/or renewal and/or changes/variations dossiers, and any other regulatory documentation, within the company timelines.
Determine and execute actions necessary for licenses and regulatory procedures to comply with domestic and international licensing requirements.
What your responsibilities will be:Assess worldwide regulatory product registration strategy.Review and, if needed, prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.Review and, if needed, prepare and send official responses to any Health Authority questions.Represent the regulatory function in communication with affiliates, outside companies, and Health Authorities.Review and assess regulatory impact for product or manufacturing changes.Manage/coordinate that licenses are adapted to current regulations.Coordinate/approve packaging material.Organize the work of the technicians under their responsibility and supervise the fulfillment of the annual projects, when applicable.Know the legislation applicable to different projects.Support general matters of the Regulatory Affairs Area.Coordinate SOPs preparation.Who you are:You have a Bachelor in Science Degree (Pharmacy, Chemistry) or Engineering.You have at least 5 years of experience in this area.Your English is advanced.Rigor and ability to work as part of the regulatory team and with cross-functional teams to meet objectives.Flexible and adaptable to changing situations/projects within the company/industry.Ability to work under tight timelines to meet deadlines and business objectives.Troubleshooting skills.Ability to clearly communicate verbally and in writing.Proactive and positive attitude.Strong analytical skills and ability to summarize and evaluate.Skills with the use of MS tools.What we offer:Permanent Contract.Full Time timetable.Attractive Benefits of being part of Grifols team.Location: San Cugat del Vallés (hybrid).
Flexibility for U Plan.Grifols is an equal opportunity employer.
#J-18808-Ljbffr