Senior CMC Regulatory Strategy Leader

Grifols; Sant Cugat del Vallès; Híbrido; EUR 50.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid Model

Flexible schedule

Descripción de la vacante

Grifols is seeking a Regulatory Affairs professional to prepare, review and manage CMC submissions and coordinate with Health Authorities across global sites. The role requires experience in RRAA within the pharmaceutical industry and a proactive approach to submission preparation.

The position is based in Sant Cugat del Vallès with a hybrid work model, offering flexible schedules and opportunities to interact with international regulators and affiliates.

Formación

• Bachelor's Degree in Health Sciences.
• Experience in RRAA within the pharmaceutical industry.
• Flexible and adaptable to changing situations/projects.
• Ability to work independently and initiate contacts for submission preparation.
• High attention to detail and problem-solving skills.
• Ability to research and interpret regulatory requirements.

Responsabilidades

• 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 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.

Conocimientos

Regulatory affairs

Spanish (Advanced)

English (Advanced)

Educación

Bachelor's in Health Sciences

Herramientas

MS Office

Document Management System

Descripción del empleo

Grifols is seeking a Regulatory Affairs professional to prepare, review and manage CMC submissions and coordinate with Health Authorities across global sites. The role requires experience in RRAA within the pharmaceutical industry and a proactive approach to submission preparation.

The position is based in Sant Cugat del Vallès with a hybrid work model, offering flexible schedules and opportunities to interact with international regulators and affiliates.