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Regulatory Affairs Specialist

Ubicación: 

Sant Cugat del Valles, ES

Tipo de Contrato:  Temporal tiempo completo
Área:  Registros
Número de solicitud de puesto:  211648

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Help us lead one of the world’s largest pharmaceutical companies!

 

The Regulatory Affairs Specialist will be responsible of the compilation, submission and following up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation.

 

What your responsibilities will be

 

You will have the opportunity to:

 

  • Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.

  • Prepare and send official responses to any Health Authority questions.

  • Review and assess regulatory impact for product or manufacturing changes.

  • Adapt licenses to current regulations.

  • Manage/coordinate the delivery of product samples or labels related with product registration/renewal/change processes.

  • Revise, approve and/or coordinate packaging material.

  • Revise/coordinate translations.

  • Write and Manage SOPs.

  • Review technical documents to ensure coherence and compliance with regulatory requirements. 

 

Who you are

 

  • You have a Bachelor's Degree in Health Sciences.
  • You have 2-3 years’ experience in Regulatory Affairs. 
  • You have Advanced level of Spanish and English (C1) and of MS Office (Excel).
  • You have analytical skills, attention to detail, and ability to summarize and evaluate.

 

What we offer

 

  • Flexible schedule: Monday-Thursday 8-9 to 17-18h and Friday 8 to 15h.​​​​​​​
  • Benefits package.

 

This 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. If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply. We look forward to receiving your application!

 

Grifols is an equal opportunity employer.

Location: Sant Cugat del Valles || SPAIN : España : Aigües de Vilajuïga || SPAIN : España : Barcelona || SPAIN : España : Coslada (Madrid) || SPAIN : España : Derio || SPAIN : España : Expat || SPAIN : España : Leioa || SPAIN : España : Mondragón (Arrasate) || SPAIN : España : Parets del Valles || SPAIN : España : Sant Cugat del Valles || SPAIN : España : Santa Cruz de Tenerife || SPAIN : España : Santiago Compostela || SPAIN : España : Sevilla || SPAIN : España : Torres de Cotillas || SPAIN : España : Valencia || SPAIN : España : Zaragoza:SC1 

 

Learn more about Grifols