Regulatory Consultant

The position is to start in one week and paying up to £75/ hour.

Responsibilities include managing all aspects of regulatory affairs relating to established products and contribute to the development and implementation of optimal regulatory strategies for development products and thereby ensure regulatory and commercial success. Including:

- Providing input to the development of regulatory and clinical strategies for development and established products to ensure timely introductions and a strong claims profile.
- Timely preparation and submission of regulatory documentation, including for marketing authorisation, variations and notifications to ensure continuity of existing product availability and that product launches occur to planned timescales. Anticipate potential issues and propose solutions.
- Prepare and review SmPCs, PILs and labelling and arrange and participate in consultation with user-groups for PILs to ensure high quality and compliance with regulations
- Prepare and review regulatory documentation and authorisations for clinical trials and advise clinical research colleagues on local regulatory and ethical requirements to ensure high standards and successful trial completion.
- Prepare and review technical, pre-clinical and clinical reports for regulatory submissions which evidentially support Alliance products.

If interested, please do let me know urgently as they are looking to make a decision by the beginning of next week. If you know anyone who might be interested please do let me know, as we offer up to £200 in vouchers if successfully placed.To find out more about Real Staffing please visit www.realstaffing.com