Cargando...

Regulatory Affairs Specialist

Ubicación: 

Sant Cugat del Valles, ES

Tipo de Contrato:  Temporal tiempo completo
Área:  Registros
Número de solicitud de puesto:  211647

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:

 

  • Assist in the registration of Grifols products by preparing, submitting and following up documentation needed for registration worldwide.
  • Prepare and send the renewal or changes dossiers of existing products.
  • Support regulation changes, answering official requests from Health Authorities, review packaging material and coordinate translations and SOPs.
  • Lead or compile all materials required in new submissions, license renewals and changes; so you will work closely with internal groups.
  • Assess the impact of the changes affecting labeling, manufacturing, stability and so on.
  • Coordinate the delivery of product samples or labels related with product registration, renewal or change processes.
  • Review technical documents to ensure coherence and compliance with regulatory requirements.

 

Who you are

 

  • You have a Bachelor's Degree in Health Sciences: Pharmacy, Biology, Veterinary, Biochemistry, Chemistry. Master’s Degree in Pharmaceutical Industry or Regulatory Affairs would be a plus.
  • You have 2-3 years’ experience in Regulatory Affairs, preferably in Medical Devices / ivd.
  • 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: 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