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Regulatory Compliance Specialist

2 months ago

Reading, Reading, United Kingdom Gleeson Recruitment Group Full time
Job Overview

Position: Regulatory Compliance Specialist

A leading specialty pharmaceutical organization is looking for a Regulatory Compliance Specialist to enhance their team. This position is pivotal in the preparation and submission of accurate new Marketing Authorizations (MAs) and the management of product licenses throughout their lifecycle, including variations aligned with the established strategy.

Key Responsibilities:

  • Ensure that product licenses in the designated markets adhere to regulatory standards and the practices of manufacturing sites.
  • Prepare and submit variations (DCP/MRP/National) in accordance with variation regulations, standard operating procedures (SOPs) where applicable, and the requirements of national Competent Authorities.
  • Guarantee that submissions are completed within the agreed timelines and comply with current health authority regulations.
  • Communicate with relevant functional stakeholders regarding any delays or scheduling conflicts that may impact regulatory plans.

Qualifications:

  • Solid regulatory experience within the pharmaceutical sector.
  • Proficient in managing regulatory submissions on a global scale.
  • Prior experience in engaging with health authorities.
  • Familiarity with EU and global regulatory frameworks.

Compensation and Benefits:

A competitive salary along with a comprehensive benefits package is available.