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Regulatory affairs specialist nat

Vallés
Grifols
Publicada el 30 abril
Descripción

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.

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 let us know.

Responsibilities

Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.

Prepare technical documentation based on the R&D inputs.

Coordinate the preparation of the documents needed for regulatory submissions with R&D, manufacturing and QA departments.

Define the regulatory requirements for the products.

Prepare and send official responses to any Health Authority questions.

Review and assess regulatory impact for product or manufacturing changes.

Adapt licenses to current regulations.

Manage/coordinate the delivery of product samples or labels related with product registration/renewal/change processes.

Revise, approve and/or coordinate packaging material.

Review technical documents to ensure coherence and compliance with regulatory requirements.

Qualifications

Have a Bachelor's Degree in Health Sciences or engineering.

Have experience in RRAA or technical departments within the pharmaceutical industry.

Have analytical skills, attention to detail, and ability to summarize and evaluate.

Have Advanced level of Spanish and English (C1).

Benefits and EmploymentFlexibility for U Program: Hybrid Model

Contract of Employment: Permanent position

Grifols is an equal opportunity employer.

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