Regulatory Project Manager

3 days left

Location
Home-Based
Salary
Up to £48,000
Posted
01 Feb 2021
Closes
03 Mar 2021
Ref
49732
Contact
Andy Leake
Discipline
Project Management
Hours
Full Time
Contract Type
Permanent
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.

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

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