Regulatory Affairs Associate, CMC, contract job, biotechnology
Your new company
This global biotech is looking to strengthen their Regulatory Affairs team with a Regulatory Affairs Associate to join the CMC team on a contract basis, initially 12 months
Your new role
As Regulatory Affairs Associate CMC you will be responsible for organization and preparation CMC documents for filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions and participate in the gathering, consolidating and analysing regulatory intelligence for all regions and support its application to product-specific activities by maintaining templates for regional requirements.
As Regulatory Affairs Associate CMC you will take a lead in documenting CMC submissions and archiving documents in document management systems.
What you'll need to succeed
In order to be considered for this contract job as Regulatory Affairs associate CMC you must have experience of pharmaceutical/biotechnology or medical device industry with a focus on Regulatory Affairs
It is essential you have strong communication skills - oral and written organizational skills and an understanding of drug development process in particular CMC- specific regulatory knowledge & experience
What you need to do now
For more information on this or any other Regulatory affairs contract jobs please apply to this advert and ask for Victoria Dunlop
- Module 3
- Regulatory Affairs Associate