Regulatory Affairs Specialist

4 days ago


Leicester, United Kingdom Star OUTiCO Full time

**Leicester**

An exciting opportunity to join the Regulatory Affairs team, in charge of maintenance and compliance of approved products, including contact with the relevant stakeholders for information as required to ensure timelines are adhered to, to meet business needs.

**Company Overview**:
Our client is an established UK based company that provide an extensive portfolio of pharmaceuticals and medical devices that offer bespoke value to patients and Healthcare Professionals (HCPs). Through continued success, they have achieved enormous growth in the past five years.
- Devoted to delivering value to patients and Healthcare Professionals
- Competitive salary and extensive benefits package

**Job Overview**:

- Submission, maintenance, and control of regulatory information and documentation for products
- Coordinate with internal and external stakeholders to prepare responses to requests for information from regulatory authorities within stated timelines
- Assist with regulatory due diligence of new products using knowledge of current regulations and guidance
- Maintain awareness of existing and new legislation/guidance relating to role and products within the region as required
- Maintain awareness of new and existing legislation and guidance from regulatory competent authorities

**To be successful**:

- Degree in a scientific or similar discipline.
- 1-2 years regulatory experience
- Highly organised with good attention to detail.
- Task orientated and diligent.
- Scientific writing

**How to apply**:



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