This opportunity comes at an extremely exciting time for this ever growing pharmaceutical brand. The 12 month FTC has the potential of an extension to join on a permanent basis. The core responsibilities of this role include:
Responsible for the preparation, distribution and control of registration documentation required for regulatory submissions to high standards and within agreed time lines to ensure that marketing authorisations are obtained and maintained in line with the company's requirements:
Prepare or manage the preparation of marketing authorisation application documentation to the highest possible standards, within the required time frame, for submission to the regulatory authorities
Monitor the progress of submissions and organise the efficient preparation and submission of responses to deficiencies noted by regulatory authorities, facilitating the earliest possible approval.
Create and review, as required, local labelling, leaflet and summary of product characteristics documentation, ensuring compliance with current legislation and registered particulars, for submission to the regulatory authorities
Ensure all regulatory activities required for product launches are completed in line with company launch plans.
Ensure all marketing authorisations are updated with new safety information in a timely manner (in line with KPIs) and ensure Company Core Safety Information is incorporated into local labelling according to corporate requirements.
Ensure all the necessary maintenance activities for local marketing authorisations are completed e.g. Sunset Clauses
Ensure the regulatory department complies with company policies and SOPs, national and global regulatory requirements, GxP guidelines.
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales