Regulatory Affairs CMC Manager - Biologics
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|Area||North London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 60,000 ~ 70,000 Annual Rate|
I am currently partnering with a ground breaking clinical stage biotechnology company who are looking to expand their talented team by hiring a Regulatory CMC Manager to work alongside their CMC Director. With a growing clinical portfolio, early phase Regulatory CMC experience is needed for this position. Ideally the successful candidate will have a biotech or biologics background and experience working with rare disease products, although this is notessential.
This is an excellent opportunity to join an outstanding organisation going through a period of growth and development and plays a pivotal role in developing life changing medicines.
· To work closely with other regulatory sub-teams to develop CMC regulatory strategy, prepare CMC regulatory documents, contribute in regulatory meetings and ensure ongoing compliance.
· Provide regulatory input to help shape CMC regulatory strategy, identifying potential regulatory challenges and tools for optimising the time/cost/risk profile.
· Preparation of CMC regulatory documents including managing writing/reviewing timelines and compiling finished documents
· To work on responses to CMC regulatory questions, CMC scientific advice briefing documents, CMC Module 2 and 3 documents, PIP/PSP, PRIME, Breakthrough/RMAT, etc.
· To co-ordinate company preparations for CMC meetings with regulatory agencies
· Strong scientific background
· Educated to at least degree level preferably in a biological science or pharmacy
· Technical and/or regulatory experience of biologics
· Experience of regulatory strategies for rare disease and/or novel platform development is desirable
This position may require a small amount of travel to meetings in Europe, US or further afield as the role requires.
For further information on this position please get in contract with Natalie Jones on 0207 183 5059 or email Natalie directly at email@example.com