Regulatory Affairs Specialist

hace 4 semanas


Valencia, Valencia, España Grifols, S.A A tiempo completo

Grifols, S.A is a global healthcare company dedicated to improving the health and well-being of people worldwide. We are leaders in plasma-derived medicines and transfusion medicine with operations in over 110 countries. Our commitment to diversity adds value to our business, teams, and culture.

Job Description

  • We are seeking a Senior Regulatory Affairs Specialist to join our Biopharma Regulatory department.

Responsibilities:

  1. Prepare, review, and manage complex submissions and follow-up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  2. Communicate with affiliates, outside companies, and Health Authorities.
  3. Represent the regulatory function on project teams as related to worldwide product registrations.
  4. Adapt licenses to current regulations.
  5. Maintain tracking of product registrations.
  6. Support other departments, affiliates, and third parties in any required regulatory information.
  7. Create regulatory affairs policies and procedures.

Requirements:

  1. Bachelor's Degree in Life Sciences field preferred.
  2. Minimum 2 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience.
  3. Experience with applicable worldwide regulatory product registrations laws and regulations.
  4. Experience of eCTD/CTD submissions, and dossier lifecycle management.
  5. Advanced level of English.
  6. User of Microsoft Office tools.

What We Offer

A competitive salary of $80,000 - $100,000 per year, plus benefits package and flexible schedule. This is a temporary position #J-18808-Ljbffr.



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