Provides effective regulatory support to the UK and global organisations for maintenance of assigned Marketing Authorisations (MAs) whilst developing knowledge of all aspects of life cycle management.
Responsibilities for a number of MAs for which the following activities will be required:
Works closely with global and local colleagues to advise and agree on regulatory strategy and data requirements.
Critically evaluates submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes
Monitors and influences assessment process to expedite and optimise the outcome of their submissions. Drive negotiations with MHRA to ensure best possible outcome which may include for example, optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.
Ensure Communication of any regulatory changes to the business as necessary to support licence compliance
Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material.
Contributes to the continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
Assists senior RA team members with new MA submissions eg Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness
Provides regulatory advice to global and UK business on all aspects of maintenance work including advice on data requirements, strategy, medicines legislation/guidelines, to ensure informed decision making and best chance of optimal assessment timing and outcome.
Provides support for divestment and in-licensing opportunities.
Proactively builds relationships externally (MHRA) and internally (BU, MI, Patient Safety, Global colleagues), so that business needs are met.
Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales