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Regulatory Affairs Specialist
hace 3 meses
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. 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 people.
That's why we need a Regulatory Affairs Specialist like you.Mission Execute clinico-regulatory activities for programs under your responsibility which are under development and/or life cycle management
What your responsibilities will be Under supervision of your manager, together with internal stakeholders, prepare regulatory dossiers, submit and follow-up procedural applications Clinical trial applications and related documents (IND, IMPD) in liaison with the Clinical Study Team and the CRO Orphan drug designations and pediatric plans as applicable Perform a QC of development regulatory dossiers prepared by other specialists as needed Provide clinico-regulatory support for license extensions or variations for International Review dossiers when applicable Respond to queries raised by Competent Authorities Maintain his/her regulatory knowledge of the regulation and of the environment 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 Pharmacy or Scientific Degree Minimum 2-year experience in Regulatory Affairs, ideally dealing with clinical trials, within the pharmaceutical industry or Clinical Research Organizations Ideally, experience with the EU Clinical Trial Regulation and the EU/EEA Clinical Trials Information System (CTIS) Good knowledge of GCP Organized and prioritize tasks Task oriented, rigorous, with good communication Facilitates information sharing and keeps supervisors updated Ability to escalate any difficulties and to identify risks Advanced English and Spanish What we offer It's a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function Regulatory Affairs Specialist help you grow professionally.
Information about Grifols is available at If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.Grifols is an equal opportunity employer.
Flexible schedule:
Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package Contract of Employment: Temporary position
Flexibility for U Program: 2 days remote working
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