Regulatory Affairs Specialist

Grifols Shared Services North America, Inc; Sant Cugat del Vallès; Presencial; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid model

Flexible schedule

Descripción de la vacante

Grifols, a global healthcare company, seeks a Regulatory Affairs professional to lead worldwide regulatory strategies for product registrations and lifecycle management. You will prepare and submit dossiers, coordinate responses to Health Authority inquiries, and supervise regulatory activities across markets.

Ideal candidates have a health sciences or engineering background, strong analytical skills, and fluency in Spanish and English (C1) with MS Office expertise.

Formación

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

Responsabilidades

• 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.

Conocimientos

Analytical skills

Attention to detail

Summarize and evaluate

Educación

Bachelor's Degree in Health Sciences or engineering

Herramientas

MS Office (Excel)

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 of product 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.

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,

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, 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: Sant Cugat del Vallès.

www.grifols.com

Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Type: Indefinido tiempo completo

Job Category: AREA TECNICA OPERACIONAL