HUB Submissions Manager

CK Group are recruiting for a Submissions Manager, to join a company in the Pharmaceutical industry, at their site based in Sandwich, on a contract basis for 12 months.

Salary:

From £20.79 per hour

PAYE to £29.12 per hour via Umbrella.

Submissions Manager Role:

• Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.
• Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood.
• Actively participate in the definition, investigation and implementation of national, regional and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
• Operate as Subject Matter Expert in dossier types and/or processes.
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.

Your Background:

• Hold a degree in a relevant scientific subject i.e. Pharmacy, Life Sciences, Business or Information Technology (desirable) or have equivalent working experience.
• Demonstrated coordination of activities in a highly regulated environment.
• Relevant experience in electronic submissions build within the Pharmaceutical Industry.
• Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
• Knowledge of drug development process.

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:

This role is based at our clients site in Sandwich.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote reference 128 094 in all correspondence.

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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