Regulatory Affairs Specialist

hace 1 día

Barcelona, Barcelona, España Grifols A tiempo completo
Job Description

Job Title: Regulatory Affairs Specialist - Packaging

Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist - Packaging to join our Biopharma Regulatory department at Grifols. As a key member of our team, you will be responsible for ensuring compliance with regulatory standards and guidelines for packaging and labeling of our products.

Key Responsibilities:

  • Prepare, review, and follow up on documentation generated at the Regulatory Affairs department or needed for a regulatory submission, ensuring timeliness, accuracy, and compliance with regulatory standards.
  • Request and obtain necessary documentation from other Grifols departments, affiliates, outside companies, or health authorities for regulatory submissions.
  • Maintain regulatory record filing systems for Regulatory Affairs in both hard copy and electronic formats, process incoming and outgoing correspondence.
  • Represent the regulatory function on project teams for specified documentation generated at the Regulatory Affairs department.
  • Support other departments, affiliates, and outside companies in obtaining necessary information for regulatory submissions.
  • Create and maintain regulatory affairs working practices and standard operating procedures.
  • Assist Regulatory Affairs Specialists to meet business objectives.

Requirements:

  • Bachelor's Degree in a Life Sciences field.
  • Minimum 2 years of experience in a similar role within the pharma industry (RRAA, Documentation, Packaging).
  • Advanced level of English.
  • User of Microsoft Office tools.
  • Meticulous and detail-oriented with excellent communication and teamwork skills, as well as initiative and results orientation.

About Grifols:

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions. We believe that diversity adds value to our business, our teams, and our culture, and we are committed to equal employment opportunities that foster an inclusive environment.

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