Senior Regulatory Executive: Labelling, Gap Analysis

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Job description Posted 29 September 2020

Job Description: Regulatory Executive/Senior Regulatory Executive

(Contract worker in GRA Labelling/GRA C&EP Labelling - UK)

Purpose
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.

Expected Delivery

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

Additional information about the process

Join GSK’s vision to do more, feel better and live longer:

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Who will I be working with?

http://www.gsk.com/en-gb/careers/meet-our-people/