Regulatory & Quality Manager
We are supporting a long-standing client with further expansion of their quality team across the UK.
This new position will take a business lead for all regulatory activities to support both clinical and commercial processes. You will work closely with several manufacturing facilities across the UK and will be the internal SME on all things regulatory.
Due to an increasing and evolving product portfolio, this new function will take a direct responsibility in liaising with the regulatory bodies and work with corporate QA. The split of the role will be around 70% regulatory focused but 30% of your time will still be attributed towards quality activities.
Whilst there are several sites, travel will be minimal. However, given the growing nature of the business, there is an expectation for this role to be site based initially with some flexibility moving forwards.
For further information, please contact Mark Bux-Ryan.
Key experience:
* Established regulatory experience (minimum 5 years) within pharmaceutical sterile/biological products
* IMP experience is essential
* Track record in leading communication with regulatory bodies
* Exceptional stakeholder management skills
* Ability to work in an evolving an fast paced business
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