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Biopharma Regulatory Affairs Specialist

Biopharma Regulatory Affairs Specialist

Grifols, S.ASant Cugat del Vallès, Cataluña, España
Hace más de 30 días
Descripción del trabajo

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 that foster an inclusive environment.

We are looking for a Regulatory Affairs Specialist to join the Biopharma Regulatory department.

Responsibilities :

  • Prepare, review, and manage complex submissions and follow-up of product registrations or other regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
  • Communicate with affiliates, outside companies, and Health Authorities.
  • Represent the regulatory function on project teams related to worldwide product registrations.
  • Adapt licenses to current regulations.
  • Maintain tracking of product registrations.
  • Support other departments, affiliates, and third parties with regulatory information as needed.
  • Create regulatory affairs policies and procedures.

Qualifications :

  • Bachelor's Degree in Life Sciences or related field.
  • Preferably 2 years of relevant technical and / or regulatory experience in the pharmaceutical industry or an equivalent combination of education and experience.
  • Valuable experience with worldwide regulatory product registration laws and regulations.
  • Experience with eCTD / CTD submissions and dossier lifecycle management.
  • Advanced proficiency in English.
  • Proficiency with Microsoft Office tools.
  • Meticulous and detail-oriented.
  • Excellent communication and teamwork skills, with initiative and results orientation.
  • What we offer :

    At Grifols, we recognize our employees as our major assets. We are committed to providing an environment that encourages professional development and career growth.

    For more information about Grifols, visit . If you're interested in this exciting opportunity and meet the requirements, we encourage you to apply!

    We look forward to your application!

    Grifols is an equal opportunity employer.

    Schedule : Monday-Thursday 7 : 10-16 : 19 and Friday 8 : 00-15 : 00.

    Benefits : Benefits package included.

    Contract : Temporary position.

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    Regulatory Specialist • Sant Cugat del Vallès, Cataluña, España