Diagnostic Regulatory Affairs IH / Operations Specialist

Grifols, S.A; Sant Cugat del Vallès; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Grifols, S.A. is seeking an Immunohematology (IH) / Operations Regulatory Affairs Specialist to support the Diagnostic Regulatory Affairs department. You will prepare technical documentation, manage registrations and variations, and coordinate submissions with R&D, manufacturing and QA teams.

The role requires strong regulatory knowledge, attention to detail and fluency in Spanish and English (C1). A hybrid model and permanent contract are offered, with a schedule combining core hours and

Formación

• Bachelor's Degree in Health Sciences or engineering.
• Experience in RRAA or technical departments within the pharmaceutical industry.
• Experience in immunohematology is desirable.
• Analytical skills, attention to detail, and ability to summarize and evaluate.
• Advanced level of Spanish and English (C1) and MS Office (Excel).

Responsabilidades

• 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.
• Interpret and apply regulatory requirements and standards worldwide.
• Prepare and send official responses to Health Authority questions.
• Review regulatory impact on product or manufacturing changes.
• Adapt licenses to current regulations.
• Manage delivery of product samples or labels for registration/renewal.
• Revise, approve and/or coordinate packaging material.
• Write and manage SOPs.
• Review technical documents for regulatory coherence.
• Assist commercial teams with regulatory documentation for tenders and customers.

Conocimientos

Analytical skills

Attention to detail

Summarize and evaluate information

Spanish (C1)

English (C1)

Educación

Bachelor's Degree in Health Sciences or engineering

Herramientas

MS Office

Excel

Descripción del empleo

Diagnostic Regulatory Affairs IH / Operations Specialist

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.

Mission

We are looking for an Immunohematology (IH) / Operations Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department. The RRAA Specialist will be responsible for the preparation of technical documentation, submission, following up and controlling of product registration and/or renewal, variations dossiers, as well as giving support to Regulatory transversal project.

What your responsibilities will be

• 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 and provide guidance on the interpretation and application of regulatory requirements and standards worldwide.
• Prepare and send official responses to any Health Authority questions.
• Review and assess regulatory impact on product or manufacturing changes.
• Adapt licenses to current regulations.
• Manage/coordinate the delivery of product samples or labels related to 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.
• Assist commercial teams with regulatory documentation for tenders and customers

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 accommodation 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 RRAA or technical departments within the pharmaceutical industry.
• You have experience in immunohematology, which is highly desirable.
• You have analytical skills, attention to detail, and ability to summarize and evaluate.
• You have Advanced level of Spanish and English (C1) and of MS Office (Excel).

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 atwww.grifols.com.

We believe in diverse talent and want to remove any barriers that may hinder your participation.

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).

Contract of Employment

Permanent position

SAP / Grifols

SAP as service provider:

Grifols: