Regulatory Project Manager

3 days left

Up to £48,000
01 Feb 2021
03 Mar 2021
Andy Leake
Project Management
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Regulatory Project Manager to join a pharmaceutical company on a permanent basis. This role can be remote in the UK.

The Role:
To be responsible for preparing and submitting MAAs/NDAs and other regulatory documents to Health Authorities, and to provide Regulatory support to other projects.

Your responsibilities:
- Prepare and submit MAAs/NDAs to Health authorities (MHRA, EMA, FDA).
- Support preparation of regulatory documents and product information.
- Support the Head of Regulatory in the design and planning of development programs.
- Support the regulatory team at regulatory meetings with Health Authorities.
- Utilise, maintain, help Administer Regulatory Information Management Systems (Veeva Submissions Vault and Archive).

Your Background:
- At least a University degree in a scientific discipline.
- Proven Regulatory experience gained within pharmaceutical companies with an emphasis on hands-on MAA/NDA submissions.
- Experience with both Centralised EU and UK MHRA submissions.
- Experience with NDA/INDs with the FDA is desired.
- Experience with eCTD submissions.
- Excellent communication skills.
- Ability to work in project teams and independently to deadlines.

Entitlement to work in the UK is essential. You must also be based in the UK. Please quote reference 49732 in all correspondence.

Apply for Regulatory Project Manager

Already uploaded your CV? Sign in to apply instantly


Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB

4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.

When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.