Senior Regulatory Executive - Uxbridge
Jenni Woolley at CK Group is recruiting for a Senior Regulatory Executive to join a company in the Pharmaceutical industry at their site based in Uxbridge on a 12 month contract basis.
The Company: As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
The Location: Stockley Park was the UK's first and most successful business park. Situated close to Heathrow Airport in West London, it is home for roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the park.
The Role: The Senior Regulatory Executive will be responsible for the timely production of documentation, the management, development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information and to support regional and country product information (prescriber and patient), primarily in the EU and APJEM markets.
Primarily the Senior Regulatory Executive is accountable for
- the 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 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.
Dependent of the level of experience, this role may require:
- 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.
- 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.
Background: To succeed in this role, you should have the following skills, knowledge and experience:
- 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.
- 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.
For more information or to apply for this position, please contact Jenni Woolley on 01438 768 710 or email firstname.lastname@example.org. Alternatively please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
Entitlement to work in the EEA is essential. Please quote reference KA43383 in all correspondence.