06 ago
|
Grifols
|
Barcelona
About the company
Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación.
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.
Mission
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
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- Prepare, compile, and maintain registration dossiers and other regulatory documentation for medicinal products and medical devices within the assigned portfolio.
- Prepare, review, and submit regulatory documentation for new registrations, renewals, variations, and other regulatory procedures.
- Review and validate dossiers prepared by other team members, ensuring accuracy, quality, and regulatory compliance.
- Monitor the progress of regulatory submissions and registration procedures, liaising with regulatory authorities when required.
- Maintain up-to-date knowledge of current regulations and regulatory requirements applicable to medicinal products and medical devices, ensuring ongoing compliance.
- Coordinate the translation of regulatory documentation, ensuring accuracy, consistency, and compliance with local market requirements.
- Collaborate with cross-functional teams and external partners to ensure timely and high-quality regulatory submissions.
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.
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- 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).
Flexibility for U Program
Hybrid Model
Flexible schedule
Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same versátil start time).
Benefits package
Contract of Employment: Permanent position. xhfqzwm
Grifols is an equal opportunity employer.
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📌 Regulatory Affairs Specialist (Barcelona)
🏢 Grifols
📍 Barcelona