CMC Regulatory Consultant required (Experience Needed)

Recruiter
RBW Consulting Solutions Ltd
Location
Cambridge
Salary
£65,000.00 (Plus Benefits)
Posted
13 Nov 2017
Closes
15 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
A great Regulatory Affairs Consultancy is seeking a new CMC RA consultant to join their team on a full term basis.

The company are an expanding consultancy with two offices servicing some larger and some smaller pharmaceutical companies in the UK and internationally.

The responsibilities for this role will be as follows:

- Advising clients on regulatory strategy - o Generally consist of advising on the suitability of specifications for different development phases and different product types
- o Advising on regulatory actions for manufacturing process changes
- o Write CMC documents (IMPDs INDs etc)
- o Contribute to / advise on briefing documents for scientific advice
- o Paediatric investigation plans
- o Work on documents for marketing authorisation applications (MAA/BLA) as well.

It is likely that this role will involve working on various projects (on some you will be on your own, others may be a group project where you assist as the CMC function. Mentoring of staff could also be useful.

The successful candidate will have 8 years experience or more in Biologics / ATMP regulatory CMC with some early development experience as well as regulatory experience in clinical and non clinical and a BSc / Phd in life sciences. Experience working in a consultancy would be a distinct advantage. Gene Therapy experience would be a huge bonus.

The package for this role would be £65,000.00 plus benefits (e.g. the 10% company contribution pension scheme and more).

Does this sound like your next opportunity? - then apply now! - I look forward to hearing from you soon.