Senior Regulatory Consultant Labelling

£30000 - £35000 per annum
  1. Contract
  2. Labelling & Artwork
  3. United Kingdom
West London, England
Posting date: 18 Feb 2021

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.