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Senior Regulatory Consultant Labelling
- Contract
- Labelling & Artwork
- United Kingdom
This vacancy has now expired. Please see similar roles below...
Are you looking to establish your regulatory career?
Join a larger pharmaceutical company as a Senior Regulatory Consultant in Labelling. This is an exciting opportunity to be able to support HIV products/anti-infectives, and eventually other Therapeutic Areas. You will also be expected to provide strategic guidance within cross functional teams and regions
Job Responsibilities
- Development and maintenance of the Global Product Information (PI) for HIV products (at first intent) , in conjunction with functional experts.
- Authoring of the patient information in the Global Patient Leaflet (GPL).
- Development and maintenance of the EU product information for CP product
- Generation of responses to global and EU regulatory agency questions related to prescriber and patient information.
- Support of Local Operating Companies during implementation of Global PI wording
Skills and Requirements
- Scientific degree (life sciences, pharmacy, medicine etc)
- Proven ability to work independently and manage workload is key
- Proven leadership of cross-functional teams and the ability to work with individuals at all levels of the business.
- Active membership of the Regulatory Matrix Team and submission writing process
- Excellent understanding and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.
- Excellent attention to detail and record keeping
- Ability to meet deadlines is critical
To Apply
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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