Job Description: Regulatory Executive/Senior Regulatory Executive
(Contract worker in GRA Labelling/GRA C&EP Labelling - UK)
- In this role the individual is responsible to their line function for the timely production of documentation
- Independently perform gap analysis for UK prescribing information versus other English prescribing information documents.
- To manage the development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information
- To support regional and country product information (prescriber and patient), primarily in the EU and APJEM markets
Responsibilities and Accountabilities
- Primarily, a comparison of UK PI against other EN PIs and escalation with matrix teams to assess importance of differences and to ascertain next steps.
- the development and maintenance of the Global Product Information (PI), in conjunction with functional experts.
- the development and maintenance of the EU product information and International Product Information.
- the generation of responses to regulatory agency questions related to prescriber and patient information.
- in accordance with GSK policies and procedures.
- The development and maintenance of the Global PI, together with support of local product information requires leadership of cross-functional teams and the ability to work with individuals at all levels of the business.
- Independent completion of gap analysis of UK vs other EN PI
- Presentation of differences to matrix team members and agreement of outcome.
- Participation in the development of Development Core Safety Information (DCSI).
- Development of Global PI for NCEs/PLEs, with appropriate mentoring.
- Independent management of the Global PI for marketed products, including presentation of items at Global Labelling Committee.
- Authoring the Global Patient Leaflet (GPL) and Global Packaging Component (GPC) of the Global PI.
- Management of the development and maintenance of EU CP and MR/DCP labelling documents and IPI throughout the product lifecycle.
- Active membership of the Regulatory Matrix Team and submission writing process
- Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.
- Supporting Local Operating Companies during implementation of Global PI wording.
- Authoring responses to labelling questions from regulatory agencies.
- Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.
- Participation in mandatory training and completion of the training records.
Experience, Skills and Specialised Knowledge Required
- Life sciences degree and relevant experience or PhD or equivalent relevant experience.
- Relevant experience includes; regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic.
- Scientific Regulatory Writing – the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
- Data analysis skills.
- Therapeutic / Product Knowledge. Will have some knowledge of therapeutic area(s) and be developing a sound knowledge of a product portfolio.
- Regulatory Knowledge.
- Understanding of policy and processes relating to management of prescriber, patient and pack information in GSK.
- Appreciation of the purpose and scope of pharmaceutical regulation related to product information (particularly of the UK) and maintains an awareness of new external guidelines/policies pertaining to product information.
- Excellent communication skills
- Excellent prioritisation, organisation and, ability to manage own workload and plan.
Role is initially working from home but as restrictions ease some time in GSK House will be required
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