Job Description:
We are seeking a highly skilled Submissions Manager to join our team in the Pharmaceutical industry on a contract basis for 12 months.
Key Responsibilities:
* Drive Submission Coordination Activities
* Ongoing Liaison with Project Team and Country Representatives to Ensure Paper and Electronic Submission Requirements, Translation Requirements, and Timelines are Mutually Understood.
* Define, Investigate, and Implement Process Efficiencies for Paper and Electronic Submission Execution, Including 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:
* A degree in a relevant scientific subject such as Pharmacy, Life Sciences, Business, or Information Technology (desirable) or 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.
About Our 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.
This role is based at our clients site in Sandwich.