REGULATORY CMC STRATEGY SR SPECIALIST

Grifols, S.A; Sant Cugat del Vallès; Híbrido; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Flexible schedule

Benefits package

Temporary position

Descripción de la vacante

Grifols, S.A is seeking a Regulatory Affairs professional to manage complex regulatory submissions (CMC) and oversee change requests for multiple production sites. You will coordinate with Health Authorities and affiliates to ensure timely regulatory reporting and maintain regulatory strategy processes.

Requirements include a Health Sciences degree, experience in RRAA within pharma, and fluency in Spanish and English (C1).

Formación

• Bachelor's Degree in Health Sciences is required.
• Experience in RRAA within the pharmaceutical industry is expected.
• Advanced Spanish and English (C1) is required.

Responsabilidades

• Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls (CMC) regulatory activities.
• Evaluate change requests for Grifols production sites for regulatory reporting requirements.
• Communicate with affiliates, outside companies and Health Authorities.
• Represent regulatory function in cross-functional project teams for worldwide product registrations.
• Carry out regulatory intelligence: search for applicable new regulations and guidelines from agencies such as FDA, HC, EMA.
• Maintain CMC regulatory activities in databases.
• Create and maintain regulatory strategy SOPs.
• Support other departments and affiliates in regulatory activity.

Conocimientos

Regulatory submissions

Regulatory intelligence

Attention to detail

Independent work

Communication with authorities

Educación

Bachelor's Degree in Health Sciences

Herramientas

MS Office

Databases

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. 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: Temporary position