Regulatory Affairs Specialist
Sant Cugat del Valles, ES
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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. |
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We 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.
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.
Mission
We are looking for a Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department.
The 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.
What your responsibilities will be
- Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.
- Prepare and send official responses to any Health Authority questions.
- Preparation, evaluation, and follow-up of technical-regulatory and registration documentation.
- Prepare and review supporting documentation, technical reports or specific documentation in response to regulatory or technical queries within reasonable and established timelines.
- Prepare and/or maintain department procedures, as well as the required SOPs (Standard Operating Procedures) within the applicable regulatory scope.
- Update and maintain the Technical Dossier.
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 accommodation may be made to enable individuals with disabilities to perform the essential functions).
- You have a Bachelor's Degree in Health Sciences or engineering.
- You have experience in RRAA or technical departments within the pharmaceutical industry.
- You have analytical skills, attention to detail, and ability to summarize and evaluate.
- You have Advanced level of Spanish and English (C1) and of MS Office (Excel).
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.
Grifols is an equal opportunity employer.
Flexibility for U Program: Hybrid Model
Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
Benefits package
Contract of Employment: Permanent position
Location: Sant Cugat del Vallès.
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Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]