Regulatory Affairs Specialist

Grifols; Parets del Vallès; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

An established industry player in pharmaceuticals seeks a Regulatory Affairs Specialist to join their dynamic team. This role is pivotal in ensuring compliance with regulatory requirements and involves preparing technical documentation, coordinating submissions, and managing product licenses. The ideal candidate will possess a Bachelor's degree in Health Sciences or Engineering and have experience in R&D or technical departments. With a focus on growth and professional development, this opportunity offers a flexible schedule and a permanent position, making it an exciting prospect for those looking to advance their careers in a critical function.

Servicios

Flexible schedule

Professional growth opportunities

Formación

• Bachelor's degree in Health Sciences or Engineering is required.
• Experience in R&D or technical departments is essential.

Responsabilidades

• Prepare and send registration and renewal dossiers for products.
• Coordinate regulatory submissions with R&D, manufacturing, and QA.

Conocimientos

Analytical Skills

Attention to Detail

Summarizing and Evaluating

Advanced Spanish (C1)

Advanced English (C1)

MS Office (Excel)

Educación

Bachelor's Degree in Health Sciences

Bachelor's Degree in Engineering

Descripción del empleo

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 Specialist like you.

Responsibilities:

1. Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.
2. Prepare technical documentation based on the R&D inputs.
3. Coordinate the preparation of the documents needed for regulatory submissions with R&D, manufacturing and QA departments.
4. Define the regulatory requirements for the products.
5. Prepare and send official responses to any Health Authority questions.
6. Review and assess regulatory impact for product or manufacturing changes.
7. Adapt licenses to current regulations.
8. Manage/coordinate the delivery of product samples or labels related to product registration/renewal/change processes.
9. Revise, approve and/or coordinate packaging material.
10. Write and manage SOPs.
11. 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, which is highly desirable.
• You have an 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.

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.

Contract of Employment: Permanent position.