Senior Regulatory Consultant Labelling

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 productGeneration 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 keyProven 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 processExcellent understanding and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.Excellent attention to detail and record keepingAbility to meet deadlines is critical

To Apply

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