Regulatory Operations Manager

12 Feb 2021
14 Mar 2021
Andy Leake
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Regulatory Operations Manager to join a small, exciting pharmaceutical company on a permanent basis. This Regulatory Operations Manager role can be remote in the UK.

The Role:
To be the Operations Lead for products and to oversee the planning and execution submissions. You will also be responsible for oversight of Regulatory Systems and providing technical support where needed.

Regulatory Operations Manager responsibilities:
- Oversee the development and maintenance of processes, templates, standards, and guide sheets for submissions.
- Independently format, publish, transmit and archive all submission types.
- Track submission statuses and management timelines.
- Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs.
- Stay updated of new guidance released by health agencies and implementing changes where needed.

Your Background:
- At least a University degree in a scientific discipline.
- Proven Regulatory Affairs experience within pharma.
- Strong experience independently managing and publishing of major regulatory submissions for investigational or marketed products to global health authorities in eCTD format.
- Proven knowledge of global health authority regulations.
- Technical experience in handling eCTD Publishing tools and Submission portals is required.

Entitlement to work in the UK is essential. You must also be based in the UK. Please quote reference 49814 in all correspondence.

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