Role: Regulatory Affairs Officer
Our client is looking for a Regulatory Affairs Officer to join their team 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.
Days on site: 4-5 days
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 legislation.
* Project management experience.
Please apply if you are looking for a role within a growing pharmaceutical organization.
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