Senior Regulatory Affairs Specialist
Job Type: Permanent
Due to company growth and expansion my client, a leading provider of generic medicines has an exciting vacancy for a Senior Regulatory Affairs Specialist to join their team. You will be specialising in licensed product regulations to ensure that all products comply with UK and international regulatory guidelines. You will work closely with a Regulatory Assistant and a number of Regulatory Consultants to drive the business forward.
- Lead and manage the Regulatory Department team to ensure high standards are maintained at all times.
- Manage and maintain a system to track all relevant stages relating to registration and licensing.
- Support internal and external audits by regulatory agencies as required
- Support Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers
- New product development and modernisation of existing Company formulas o Have a clear understanding of the requirements for registration of products inour International markets
- 5 years + previous Regulatory Experience
- Bachelor of Science degree (or related discipline) essential
- Experience of working with regulatory bodies such as MHRA