Regulatory Affairs Officer

Role:Regulatory Affairs Officer

Oue client is looking for a Regulatory Affairs Officerto join theirteam to support all aspects of Parallel Trade (PLPI), Regulatory Affairs, and Quality Management. You will work closely with the Regulatory Affairs Lead and Senior Specialists to ensure high standards in implementing Quality and Regulatory strategies, adhering to MHRA guidelines.

Key Responsibilities:

• Submit and implement new licenses/variations promptly.
• Collaborate with MHRA, Quadrant License Teams, and Pharmagen to ensure smooth production processes.
• Maintain licenses within the Quality Management System.
• Stay updated on training, processes, and regulations.
• Identify and escalate regulatory risks.
• Process license applications to minimize MHRA RFIs.
• Support Pharmagen Production and Quality Departments.

Experience:

• Experience in Regulatory Affairs and Parallel Trade.
• Deep understanding of the pharmaceutical industry and its products.
• Expertise in Quality Management Systems, Deviations, Change Controls, Risk Assessments, Validations, and MHRA Systems.
• Organized, proactive, and commercially aware.
• Strong communication and teamwork skills.
• Flexible, creative, and a problem solver with analytical abilities.
• Proficient in Excel, data analysis, and decision-making tools.
• Knowledge of patents and trademark legislations
• Project management experience.

Please apply if you are looking for a remote role within a growing pharmaceutical organisation.