Regulatory Affairs Specialist

DESCRIPCIÓN DE LA OFERTA

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 20.000 people. That’s why we need a Regulatory Affairs like you.

The Regulatory Affairs 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

You will have the opportunity to :

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.

Write and Manage SOPs.

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

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).

You have a Bachelor's Degree in Health Sciences or engineering

You have been working in R&D or technical departments

You have experience in immunohematology, highly desirable.

You have Advanced level of Spanish and English (C1) and of MS Office (Excel).

You have analytical skills, attention to detail, and ability to summarize and evaluate.

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 such as Regulatory Affairs. We’ll help you grow professionally.

Information about Grifols is available at ’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 : Permanent position

Location : Parets del Vallès