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Regulatory Compliance Specialist

1 week ago

Dubai, Dubai, United Arab Emirates Grifols, S.A Full time

Grifols, S.A. is a global healthcare company dedicated to improving the health and well-being of people worldwide.

Job Description:

The Regulatory Affairs and Quality Specialist role plays a vital link between Grifols and regulatory authorities, ensuring compliance with applicable regulations and planned timelines.

Key responsibilities include:

  • Supporting the Scientific Office Manager in obtaining timely approvals for product registration, re-registration, and variations with the relevant authorities.
  • Actively following up on submissions to resolve any regulatory issues efficiently.
  • Anticipating and responding to regulatory and technical queries from competent authorities.
  • Assisting in closing deficiencies or observations raised by regulatory bodies.
  • Monitoring regulatory updates and ensuring compliance with new legislation to develop effective regulatory strategies.
  • Managing regulatory correspondence between Grifols and competent authorities.
  • Reviewing product artwork and promotional materials to ensure compliance with regulations.
  • Liaising with the local Qualified Person for Pharmacovigilance, supporting safety reporting, compliance with local legislation, audits, and inspections.
  • Supporting the renewal of office licenses and ensuring compliance with scientific office requirements.
Requirements:

To succeed in this role, candidates must meet the following criteria:

  • Bachelor's degree in Pharmaceutical Sciences.
  • 2–4 years of experience in Regulatory Affairs or a related field.
  • Strong knowledge of regulatory requirements and compliance.
  • Excellent communication and stakeholder management skills.
  • Ability to work in a fast-paced, international environment.
  • Detail-oriented with strong problem-solving abilities.