Description
My client, an international company located in Basel, Switzerland is urgently looking for a Regulatory Affairs (Submissions) Specialist. The right candidate should start as soon as possible and the contract has a duration until the end of the year (extension possible).Please find the details of the position below.
Responsibilities
Management, organization, assembly, production and delivery of high quality submissions (electronic and/or paper) to the appropriate Health Authorities (EU/US)
Major accountabilities
* Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned regulatory submissions. Ensure adherence to internal standards and processes, as well as Health Authority's requirements.
* Ensures through coordination with GRA and CBUs that all participants involved in the preparation of the submission receive timely update on the submission status. Proactively tracks individual documents and submission timelines. Maintains and updates submission tracking sheet.
* Communicates openly, effectively and timely with GRA Operation counterparts on all submission issues and activities. Liaise with Global RA and CMC Manager for problem solving. Immediately notify GRA Ops management and project teams of any issues / activities that may adversely impact the submission date. Provide status report to Global RA and CMC Manager, and line management within GRA Ops.
* Is a member of and provides support to the Regulatory Affairs team in product/project support activities such as advertising and promotion, reporting requirements, licensing and registration in one or more countries, Agency registration fees.
* Support the preparation and or review of documents for submission to regulatory authorities.
* Ensures support and compliance of GRA through one or more of the following activities: maintaining and creating document templates, management of GRA internal standards and procedures, managing the GRA archive, maintenance of GRA knowledge bases and websites, monitoring regulatory publications and websites
Please apply immediately since the Interviews will take place already next week. For candidates not located in Switzerland, Skype-Interviews can be arranged.