Regulatory Affairs Manager

Grifols, S.A; Sant Cugat del Vallès; Híbrido; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid Model

Flexible schedule

Descripción de la vacante

Grifols, S.A in Spain seeks an experienced Regulatory Affairs professional to manage worldwide product registrations, renewals, and lifecycle strategies across markets. You will coordinate dossier submissions and ensure compliance with regulations.

The role leads a team of Regulatory Affairs Technicians, collaborates across functions, and guides licensing actions while staying up to date with domestic and international requirements.

Formación

• Bachelor's degree in Health Sciences or engineering.
• Experience in Regulatory Affairs in the pharmaceutical industry (RRAA or technical departments).
• Advanced Spanish and English (C1) and MS Office proficiency.

Responsabilidades

• Define worldwide regulatory strategies for product registrations, renewals, and lifecycle management across markets.
• Prepare and submit regulatory dossiers for registrations, renewals, variations and post-approval changes.
• Coordinate responses to Health Authority questions within timelines.
• Lead adaptation of licenses to current regulatory requirements and evolving legislation.
• Coordinate labeling and packaging documentation to ensure local regulatory compliance.
• Supervise Regulatory Affairs Technicians to ensure timely execution of activities.
• Monitor regulatory projects and ensure deliverables meet deadlines.
• Represent Regulatory Affairs in communications with affiliates, partners, and authorities.
• Maintain up-to-date knowledge of regulations and provide guidance for projects.
• Support department activities and SOPs.

Conocimientos

Analytical skills

Attention to detail

Summarize and evaluate

Spanish (C1)

English (C1)

MS Office / Excel

Educación

Bachelor's Degree in Health Sciences or engineering

Herramientas

MS Office

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, fostering an inclusive environment where diversity makes us outstanding.

Mission

Ensuring compliance of the priority plan, as well as coordination of compilation, submission and following up ofproduct registration and/or renewal and/or changes/variations dossiers, and any other regulatory documentation,within the company timelines. Determine and execute actions necessary for licenses and regulatory procedures are in compliance with domestic and international licensing requirements

What your responsibilities will be

• Assess and define worldwide regulatory strategies for product registrations, renewals, and lifecycle management activities across assigned products and markets.
• Review, prepare, and submit regulatory dossiers for new registrations, renewals, variations, and other post-approval changes, ensuring compliance with applicable regulations.
• Prepare, review, and coordinate responses to Health Authority questions and requests within established timelines.
• Manage and coordinate the adaptation of product licenses to current regulatory requirements and evolving legislation.
• Coordinate and approve packaging materials and labeling documentation, ensuring regulatory compliance and alignment with local market requirements.
• Organize, coordinate, and supervise the work of Regulatory Affairs Technicians, ensuring the timely and high-quality execution of assigned activities.
• Review and assess the regulatory impact of product, manufacturing, or process changes within the assigned portfolio and oversee the implementation of required regulatory actions.
• Monitor and supervise the execution of annual regulatory projects and ensure deliverables are achieved according to agreed timelines.
• Represent the Regulatory Affairs function in communications with affiliates, external partners, and Health Authorities, when applicable.
• Maintain up-to‑date knowledge of applicable regulations and regulatory requirements, providing regulatory guidance for different projects and business initiatives.
• Support general activities and strategic initiatives within the Regulatory Affairs Department.
• Coordinate the preparation, review, implementation, and maintenance of Regulatory Affairs Standard Operating Procedures (SOPs).
• Collaborate with cross‑functional teams to ensure efficient regulatory support throughout the product lifecycle.

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 experience in RRAA or technical departments within the pharmaceutical industry.
• 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.

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).

Contract of Employment:Permanent position.