Senior Manager/Director of Regulatory Affairs

2 weeks ago

Hampshire, United Kingdom Blackfield Associates Full time

Job Description Our client, a leading independent pharmaceutical company who have a wide range of specialist medications and generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire.

As Regulatory Affairs manager, you will:
Leading a small team, handling the regulatory activity across a large portfolio of medicine and licences across therapy areas including Oncology, CNS, respiratory
Working with EU, UK, and RoW regulatory bodies; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Review and support for submission of new product dossiers and technical files – both own development, in-licensed and out-licensed and all aspects of regulatory lifecycle maintenance for existing products
Regulatory Strategy and Scientific Writing
To be considered for the role of Regulatory Affairs Manager, you will have the following:
Minimum of 5 years of Regulatory Affairs experience in a relevant pharma company
Worked in a broad role, covering R&D projects and CMC knowledge- a project manager approach
Must have proven experience with EU and UK regulations for Pharmaceutical products or Combination products.
Due to the nature of the team, this person will be required at the Hampshire office at least 2 times a week. Hybrid working.

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