Direct message the job poster from Planet Pharma
Planet Pharma are partnered with a global biopharmaceutical company who are now seeking a Regulatory Affairs Manager CMC on an initial 6 month contract with potential of extension.
Key Responsibilities:
* Develops country-specific regulatory strategies and provides feedback on submission plans for multiple products.
* Collaborates with affiliate offices on strategies and activities impacting specific countries.
* Addresses CMC regional issues and ensures appropriate contingency plans for global regulatory filings.
* Manages regulatory CMC submissions (e.g., clinical trials, variations, marketing applications) in compliance with global and local requirements.
* Gathers regulatory intelligence, provides guidance on change control requests, and keeps stakeholders updated on regional considerations and new regulations.
Key Requirements:
* Degree in a relevant field
* 5+ years experience in a relevant role
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Please click ‘apply’ or contact Harry Banks (Recruiter II) at Planet Pharma for more information:
E: HBanks@planet-pharma.co.uk
T: +44 20 3808 4810
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science and Research
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
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