The Role In this role the individual is responsible to their line function for the timely production of documentation. Manage the development and maintenance of...
In this role the individual is responsible to their line function for the timely production of documentation. Manage the development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information and support regional and country product information (prescriber and patient), primarily in the EU and APJEM markets.
Role Specific Requirements
- Development and maintenance of the Global Product Information, in conjunction with functional experts.
- Authoring of the patient information in the Global Patient Leaflet.
- Development and maintenance of the EU product information and International Product Information.
- Generation of responses to regulatory agency questions related to prescriber and patient information.
- Participation in the development of Development Core Safety Information.
- 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 and Global Packaging Component 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.
- Authoring Competitive Labelling Assessments.
- 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.
- Life sciences degree and relevant experience or PhD or equivalent relevant experience.
- Relevant experience includes; regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic.
- 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.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.