Regulatory Project Manager - CMC

Regulatory Consultant / Senior Regulatory Consultant

Location: Home-based in the UK

Salary: Up to 75,000 per annum depending on experience

Permanent position

Job Reference: JO-2204-491484

Working within a CRO but directly outsourced to a pharmaceutical business, this role is a good opportunity for someone who has experienced broad working experience CMC components across all phases. In this role, you will be responsible for the planning/preparing and co-ordinating of CMC sections (Module 2.3 and 3), as well as working with pharmaceutical products across all phases.

Responsibilities include;

Project manage and monitor changes to CMC sections, working closely with module authors and reviews to ensure all risks are mitigated

Understand CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)

Maintain a project dashboard for tracking and reporting progress

Project Manage CMC sections and attend meetings as requested

Requirements include;

Regulatory understanding of CMC sections of INDs, NDAs, BLAs, etc., and supportive amendments and supplements (ICH Modules 2 and/or 3) is a plus and highly desirable

3-5 years experience within Regulatory Affairs and project managing

BA/BS in a scientific or technical discipline or advanced degree

Excellent project management skills

If you are interested in this role or would like more details please email your CV call Charlie Harris on 01189 522797

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you 250 in vouchers of your choice.