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
- 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.