REGULATORY CMC STRATEGY SR SPECIALIST

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

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

Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.

Evaluate change requests for any of Grifols production sites for regulatory reporting requirements.

What Your Responsibilities Will Be

• 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 of 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.

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.
• You have been working in RRAA within the pharmaceutical industry.
• Flexible and adaptable to changing situations/projects within the company/industry.
• Ability to work independently and initiate contacts essential to submission preparation.
• High degree of attention to detail and problem solving skills.
• Ability to research and interpret regulatory requirements.
• Computer skills (such as MS Office, databases, Document Management System).
• You have Advanced level of Spanish and English (C1).

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.

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).

Benefits Package

Contract of Employment

Permanent position

Location

Sant Cugat del Vallès.

www.grifols.com

Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]

Learn more about Grifols