Specialist, Regulatory Affairs

Elvium

Riyadh, Saudi Arabia
Not specified (assumed to be office-based due to location).
Dossier compilation and submission
Compliant life cycle management
Local labeling creation
Elvium is seeking a Specialist in Regulatory Affairs to manage dossier compilation, submission, and life cycle compliance with market regulations in Riyadh, Saudi Arabia. The role involves communication with regulatory agencies and development of regulatory procedures, making it critical for ensuring adherence to industry standards

Job Summary

  • The role is responsible for dossier compilation and submission to ensure compliant life cycle management in accordance with market regulations.
  • Candidates will manage local labeling and AWs creation while maintaining regulatory processes within the department.
  • The position requires managing communication with regulatory agencies and assisting in the development of regulatory procedures and SOPs.

Matching Summary

Match Score: 75

Elvium is seeking a Specialist in Regulatory Affairs to manage dossier compilation, submission, and life cycle compliance with market regulations in Riyadh, Saudi Arabia. The role involves communication with regulatory agencies and development of regulatory procedures, making it critical for ensuring adherence to industry standards.

Skills & Requirements

Must-have

  • dossier compilation and submission
  • compliant life cycle management
  • local labeling creation
  • regulatory agency communication

Nice-to-have

  • SOP development experience
  • process implementation skills
  • strong regulatory knowledge

Key Requirements

  • Experience in regulatory affairs
  • Knowledge of market regulations
  • Ability to manage labeling submissions

Work Rights

Not specified

Tailored Resume

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