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 presentat...