Job title: CMC Regulatory Affairs Specialist
A Neurology/Immunology Pharmaceutical Company based in Berkshire are seeking a Regulatory Affairs CMC specialist to join on a contract basis. This role will provide support, or lead as assigned, regulatory CMC submissions for all global development products.
- Support for developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products
- Responsible for writing regional and global CMC documentation for submissions as agreed with the Global Regulatory CMC Lead
- Contribute to the preparation of the CMC SWOT analysis (or regulatory Risk Capture Document) and supports associated RA CMC challenge sessions.
- Provides regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT etc.)
- Leads or provides support to cross-functional teams responsible for the preparation of responses to HA CMC questions raised
- At least 5-8 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
- Experience of participating in regulatory agency meetings on CMC matters
Knowledge of GMP requirements and standard systems
This is a 12-month contract offering an attractive hourly rate for both PAYE and LTD/Umbrella contractors.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org