Regulatory Affairs Manager
6 month contract
CMC - biologics focused
Offering up to £43.50 Per Hour PAYE
CPL Life Sciences is collaborating with a leading pharmaceutical firm who is looking for a Regulatory Affairs Manager with a background in CMC and biologics to join their established team. Within this role you will be responsible for supporting one or more regional products generating country specific regulatory strategies.
Job Responsibilities include;
• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
• Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
• Manages strategy and execution for all regulatory CMC submissions
• Gathering, consolidating and analyzing regulatory intelligence for International Markets and supports its application to product-specific activities
Candidate Requirement Include;
• Must be eligible to live and work in the United Kingdom
• Life Science degree or equivalent
• Previous CMC biologics experience
• Able to demonstrate ability to work on undefined projects and ability to adapt with clients changing needs
If this role of interest to yourself please forward your CV to email@example.com.