Regulatory Executive/Senior Regulatory Executive
(Contract worker in GRA Labelling/GRA Labelling - UK)
In this role the individual is responsible for the timely production of documentation
· 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:
The role is accountable for:
· the authoring, development and maintenance of the Global Product Information (PI), in conjunction with functional experts.
· the authoring of the patient information in the Global Patient Leaflet (GPL).
· the authoring, development and maintenance of the EU 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.
This role requires prior relevant experience and may include:
· Participation in the development of Development Core Safety Information (DCSI).
· Development of Global PI for Product Line Extensions, with appropriate mentoring.
· Independent management of the Global PI for marketed products, including presentation of items at Global Labelling Committees.
· Authoring the Global Patient Leaflet (GPL) and Global Packaging Component (GPC) of the Global PI.
· Management of the development and maintenance of EU documents through the early 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.
· Authoring Competitive Labelling Assessments (CLA)
· Authoring relevant sections of the Periodic Safety Update Report.
· 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 (Pharmacy preferred) or relevant experience, or PhD or equivalent relevant experience.
· Relevant experience includes pharmacy practice, regulatory affairs, medical affairs, clinical research, or pharmacovigilance.
· Excellent Scientific Regulatory Writing – the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
· Data analysis skills – basic understanding of biostatistics, clinical trial design, and clinical therapeutics
· Therapeutic / Product Knowledge. Will have knowledge of therapeutic area(s), particularly the HIV area, and be developing a sound knowledge of a product portfolio.
· Regulatory Knowledge.
· Basic understanding of policy and processes relating to management of prescriber, patient and pack information in GSK.
· Some appreciation of the purpose and scope of pharmaceutical regulation related to product information and maintains an awareness of new external guidelines/policies pertaining to product information.