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Regulatory CMC Strategy Senior Specialist

Hybrid in Sant Cugat del Vallès·Added 10 days ago

Grifols

100 open roles

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Overview

Job details

Hybrid
Office and home days — the ad has the split.

Requirements

Have the right to work in Spain
Grifols doesn't mention sponsorship in the ad.
Speak fluent Spanish
Listed as a requirement in the ad.
Work in English
English is required, per the ad.
Be near Sant Cugat del Vallès for hybrid days
No relocation package mentioned.
University degree
“You have a Bachelor's Degree in Health Sciences.” — per the ad.

Pay & benefits

What you'll get

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.

Requirements

What we're looking for

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.
You have been working in RRAA within the pharmaceutical industry.
Flexible and adaptable to changing situations/projects within the company/industry.
Ability to work independently and initiate contacts essential to submission preparation.
High degree of attention to detail and problem solving skills.
Ability to research and interpret regulatory requirements.
Computer skills (such as MS Office, databases, Document Management System).
You have Advanced level of Spanish and English (C1).

The role

Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.

Evaluate change requests for any of Grifols production sites for regulatory reporting requirements.

What you'll do

Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls (CMC) regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
Evaluate change requests for any of Grifols production sites for regulatory reporting requirements. Keep track of change requests in the appropriate database.
Communicate with affiliates, outside companies and Health Authorities.
Represent the regulatory function in cross-functional project teams as related to worldwide product registrations.
Regulatory intelligence: search for applicable new regulations and guidelines from various Regulatory Authorities such as FDA, HC, EMA, etc.
Keep track of CMC regulatory activities in the appropriate databases.
Create and maintain regulatory strategy working practices and standard operating procedures.
Support to other departments, affiliates and outside companies in any required regulatory activity.

How you'll work

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).

Hiring process

4 steps2 interviews

Búsqueda de empleo
Empieza tu búsqueda en la web de empleo de Grifols o únete a la Talent Community para mantenerte al día de las últimas ofertas publicadas.
Solicitud
Llamada de selección
With an equipo de selección · Phone call
Si entras en fase de preselección, el equipo se pone en contacto contigo para una breve llamada de evaluación sobre tu motivación, habilidades y experiencia, y para profundizar en los detalles clave de la posición.
Entrevistas
30–45 min
Se suelen realizar dos o más entrevistas de entre 30 y 45 minutos cada una; quien te entreviste evaluará tus habilidades y aptitudes con preguntas centradas en el puesto y en tu experiencia.
Decisión y oferta
Antes de la incorporación
Una vez aceptada la oferta comienza el proceso previo a la incorporación, con toda la información y los recursos necesarios para una transición fluida a tu nuevo puesto.

Te acompañan tres personas: responsable de adquisición de talento, responsable de contratación y HR manager.

About Grifols

Grifols is a global healthcare company headquartered in Barcelona, Spain, specializing in the development and production of plasma-derived medicines, transfusion medicine, and diagnostic solutions. With operations in over 100 countries and a workforce of more than 20,000 employees, it is one of the world's leading producers of plasma-based therapies, treating chronic and rare diseases. The company operates a vast network of plasma donation centers and manufacturing facilities, making it a key player in the biopharmaceutical industry.

In Spain, Grifols maintains its global headquarters in Barcelona and operates major production and R&D sites in the Catalonia region, including facilities in Parets del Vallès and Sant Cugat del Vallès. The company is deeply rooted in Spain, offering a wide range of roles from laboratory and manufacturing positions to IT, engineering, and corporate functions. For international professionals, Grifols provides a multicultural work environment, opportunities in a highly regulated and innovative sector, and the chance to work in a company that is a global leader in its niche, with Spanish as a common working language alongside English.

Industry: Pharma
Founded: 1909
Employees: 20,000–25,000
Headquarters: Barcelona, Spain
In Spain: Barcelona, Parets del Solès, Sant Cugat del Vallès
Website: grifols.com

Good to know if you are moving

Grifols is headquartered in Barcelona, Spain, and is one of the largest companies in the Catalan region, offering a strong local presence and career opportunities.
The company operates in a highly regulated and innovative sector, providing roles in R&D, manufacturing, and IT, which can be attractive for professionals with experience in biotech or pharma.
While Spanish is the primary language in many roles, the company's global nature means English is often used, especially in IT, corporate, and international positions.
Grifols has a strong commitment to employee development, with trainee programs and continuous learning opportunities, as seen in the STEM Trainee Program IT QA.
The company's global footprint includes operations in the US, Europe, and Asia, offering potential for international mobility within the organization.

In their own words

About the company & team

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.

Additional information

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.

Contract of Employment: Temporary position

Location: Sant Cugat del Vallès.

www.grifols.com

Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]

Learn more about Grifols

All open roles at Grifols