Location South East England
A leading pharmaceutical company is looking for a Regulatory Associate to join their regulatory product maintenance group. The role is an exciting opportunity to play a key role bring new product packaging into the market.
Roles & Responsibilities
Prepare and submit applications in a timely manner. These include new licence applications, variations, renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
- Variations to include: Type 1A and 1B labelling changes including own label supplies, safety updates and line extensions
- Manage multiple project assignments simultaneously and provide data assessment and conclusions
- Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
Experience & Requirements
- Understanding of the current UK and European regulations, laws, guidelines and industry requirements
- Knowledge of regulatory labelling, packaging and safety information updates
- Excellent organisational and planning skills
- Good interpersonal skills
- Excellent oral and written communication skills
If you have any questions, or would like more information, please contact Lisa Jones at CY Partners