Change Control and Regulatory Specialist

Grifols; Parets del Vallès; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A global healthcare company in Parets del Vallès seeks a Change Control and Regulatory Specialist. Responsibilities include preparing quality documentation for Health Authorities, coordinating change controls, and supporting regulatory affairs. The ideal candidate holds a degree in Health Sciences, has relevant experience, and is proficient in English. This is a hybrid role with a permanent position and benefits package.

Servicios

Flexible schedule

Benefits package

Hybrid work model

Formación

• Experience in a similar area within the pharmaceutical sector.
• Knowledge or experience in Regulatory Affairs will be highly valuable.

Responsabilidades

• Assist in preparation of quality technical documentation for submission to Health Authorities.
• Coordination and technical supervision of change controls.
• Preparation of PQR.
• Support in managing technical agreements with clients.
• Provide support to Medical Information.

Conocimientos

Advanced English

Proficiency in MS Office

Knowledge in Regulatory Affairs

Educación

Bachelor's or Master's Degree related to Health Sciences

Herramientas

SAP

Descripción del empleo

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.

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.

We are looking for a Change Control and Regulatory Specialist to join Instituto Grifols SA.

What your responsibilities will be

• Assist in the preparation of quality technical documentation for submission to Health Authorities for variations or new registrations
• Coordination and technical supervision of change controls.
• Preparation of PQR.
• Support in managing technical agreements with clients.
• Provide support to Medical Information regarding inquiries received from healthcare personnel or users about the stability or quality of the product.
• Communication of changes to external companies and within the group.
  

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 or Master's Degree related to Health Sciences.
• You have experience in a similar area within the pharmaceutical sector.
• To have knowledge or experience in Regulatory Affairs will be high valuable.
• Your level of English is advanced.
• Proficiency in MS Office.
• SAP is a plus.
  

What we offer

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.

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).
Benefits package
Contract of Employment: Permanent position

Location: Parets del Vallès www.grifols.com

Location:SPAIN : España : Parets del Valles:[[cust_building]]

Learn more about Grifols