Regulatory Affairs CMC Biologics home working
Regulatory Affairs, CMC, Biologics, home working, contract job, hourly rate
Your new company
This global biotech is looking for an experienced Regulatory Affairs consultant to join them on a 6 month contract (scope for extension), you will take responsibility for the successful development and implementation of regulatory strategies for multiple product modalities (small molecules, biologics and ATMPs)
Your new role
As Regulatory Affairs Consultant CMC biologics you will take a lead in clinical trial applications and new registration submissions and post-approval compliance for assigned portfolio in region as well as providing strategic guidance and regulatory leadership at project team meetings as well as represent Regulatory CMC (EU and Global Emerging Markets) strategy for assigned products in region.
You will identify and assess regulatory risks associated with the execution of regulatory strategies in assigned region, define strategies to mitigate risks and keep abreast of changes in regional legislation.
What you'll need to succeed
In order to be considered for this Regulatory CMC Biologics contract job you must have experience within Regulatory CMC aspects of clinical trial applications in the EU would be highly desirable (ATMPs in particular) and experience with global Regulatory CMC registrations and variations would be desirable. There is the option to work from home 2 days per week after an initial on-boarding period
What you need to do now
For more information on this or any other Regulatory Affairs CMC Biologics contract job please apply to this advert and ask for Victoria Dunlop
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