Senior Manager/Director of Regulatory Affairs

2 weeks ago

Hampshire, United Kingdom Blackfield Associates Full time

Our client, an independent pharmaceutical company who manufacture and specialising in 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 medical device/ combination products
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:
Minimum of 5 years of Regulatory Affairs experience in a relevant pharma environment
Worked in a broad role, covering R&D projects and CMC knowledge
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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