Regulatory Affairs Contractor - 1 year Fixed Term (potential opp
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|Area||West London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 40,000 ~ 50,000 Annual Rate|
We are currently partnering with a global Generics company looking for a Regulatory Affairs contractor to support their lean Regulatory team. This is an excellent opportunity to work closely with various function heads across the business. This is a truly global position working with various countries and regions all over the world daily. The successful candidate will be part of a lively, enthusiastic team which is set in a very friendly environment.
Salary - £40,000 - £50,000 circa + Package
Location – West London
· Working as part of a team to ensure the company and its partners are aware of all regulatory requirements and meet pre-defined submission timelines.
· Knowledge of CMC filings.
· Working with labeling teams for artwork changes and implementation (tech transfers and post approval maintenance)
· Collaborate with cross functional team to ensure overall project remains on time
· Work with cross functional team and contract manufacturers to ensure successful and timely transfer of products to new CMO.
· Compile and submit appropriate variations to support drug product manufacturing transfers, and other variations such as batch release, labeling etc.
· Assist team with labeling updates as required to ensure timelines remain on target.
· Responsible for overall document management and regulatory data consolidation for all products into information software
For further information please get in touch with Natalie Jones via email@example.com or call 0207 183 5059