Regulatory Affairs Specialist Lead

hace 3 semanas


Barcelona, Barcelona, España Grifols A tiempo completo
About Grifols

Grifols is a global leader in plasma-derived medicines and transfusion medicine, with a rich history spanning over 110 years. We are committed to improving the lives of millions of people around the world through innovative medicines, solutions, and services.

We believe that diversity adds value to our business, teams, and culture. Our commitment to equal employment opportunities fosters an inclusive environment where our employees can thrive.

Job Overview

This is a temporary position with a competitive salary range of $80,000 - $120,000 per year, depending on location and experience. The successful candidate will join our Biopharma Regulatory department and contribute to the development and implementation of regulatory strategies.

You will work closely with cross-functional teams to ensure compliance with regulatory standards and guidelines. This includes preparing and managing complex submissions, communicating with affiliates and health authorities, and representing the regulatory function on project teams.

Responsibilities
  1. Prepare, review, and manage complex submissions and follow up of product registrations or any other regulatory activity.
  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

To succeed in this role, you will need a Bachelor's Degree in Life Sciences and a minimum of 2 years of related technical and/or regulatory experience in the pharmaceutical industry. You must have experience with worldwide regulatory product registrations laws and regulations, as well as advanced level English skills.

You should be meticulous and detail-oriented, with excellent communication and teamwork skills. Experience with eCTD/CTD submissions and dossier lifecycle management is highly desirable.



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