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Regulatory Affairs Manager, CMC - Home Based
134558
Posted:
13th
November 2023
- 450 GBP - 450 GBP
- Hybrid, Cambridge, United Kingdom
- Contract
** New Contract - Regulatory Affairs Manager, CMC - Global Biotech - Hybrid, Cambridgeshire **
Thrilled to be working on this brand new long term contract vacancy with my Global Biotech client based in the UK.
We are searching for a Regulatory Affairs Manager, CMC to join their team for a minimum period of 12 months.
Specific Job Requirements
We have a 12 month contract opportunity for a Manager Regulatory Affairs CMC to join our Regulatory Affairs Team based in Cambridge.
Core Duties include:
If you are suitable, available and interested in this post, please do not hesitate to get in touch.
Brendan Mulvaney
020 3019 3985
Thrilled to be working on this brand new long term contract vacancy with my Global Biotech client based in the UK.
We are searching for a Regulatory Affairs Manager, CMC to join their team for a minimum period of 12 months.
Specific Job Requirements
We have a 12 month contract opportunity for a Manager Regulatory Affairs CMC to join our Regulatory Affairs Team based in Cambridge.
Core Duties include:
- Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa).
- Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
- Co-ordinate the preparation of responses to CMC questions from regulatory authorities
- Maintain an up-to-date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner
- Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
- Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
- Well versed and competent with regulatory documentation and submission management systems
- Excellent verbal, written and interpersonal communication skills are required
- Must have excellent organizational skills and an ability to work on a number of projects with tight timelines.
If you are suitable, available and interested in this post, please do not hesitate to get in touch.
Brendan Mulvaney
020 3019 3985
Brendan Mulvaney
Lead Consultant