Regulatory Affairs Manager CMC biologics

This biopharmaceutical company specialises in rare diseases and is looking for a Regulatory Affairs Manager CMC contractor. This is a 12-month contract job with scope for months

You will be responsible for EU and ROW markets, managing the authoring and compilation of all necessary CTD and regional administrative documentation for CMC-related worldwide regulatory submissions, through direct liaison with globally located Regulatory and Technical Operations team members.

Ensure submissions are high quality, and that the content and format of regulatory submissions comply with regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.

In order to be considered for this contract job as Regulatory Affairs Manager in the CMC team, you must have experience working in biologics. Unfortunately, without these applications, it won't be considered.

For more information on this or any other Regulatory Affairs biological CMC contract jobs, please apply to this advert