Regulatory Project Manager

Job Title:

Regulatory Project Manager

Job Type:

Full Time

Country:

UK-based

Location:

Home-based

Diurnal is a UK-based specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions. We are currently in an exciting period of growth in the development of new products, and our expansion has resulted in the creation of a new opportunity to join our regulatory team.

We have an excellent opportunity for a scientist with substantial experience in pharmaceutical regulatory affairs, with knowledge of both clinical trial and marketing authorisation applications.

The successful candidate will support Diurnal’s regulatory efforts on all development projects, manufacturing improvements, and registration and licensing for all established products, including lifecycle management.

They will prepare all product information (including artwork) and provide advice and support to ensure all manufacturer/importer and wholesale dealer licenses are maintained, as well as regulatory compliance with all change controls and SOP activities, in accordance with GCP and GMP.

The full job description is available here

UK-based, but working from home, the job requires regular travel to meetings mainly in London or Cardiff.

Candidates must be fully experienced in pharmaceutical regulatory affairs, including electronic submissions, monitoring publishing and centralised EU MAA and US FDA NDA and IND regulatory procedures.

Diurnal offers a competitive salary and excellent benefits.

Email our HR Advisor Graham Frankel grahamfrankel@diurnal.co.uk enclosing your CV.

 

APPLY ONLINE

You are applying for the following position:

Regulatory Project Manager

Job Type:

Full Time

Country:

UK-based

Location:

Home-based

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