Regulatory Submission Publisher
Posted on May 2, 2021 by RM IT Professional Resources AG
Regulatory Submission Publisher vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Previous preclinical and/or clinical RA experience especially with submission of INDs and CTAs
- Working experience with compliance practices, such as eg GxPs, SOPs or equivalent
- Knowhow in project management and working within a Matrix environment with the ability to influence cross functional teams
- Familiarity with external regulatory environment related to drug development and document management systems
- Bachelor's degree or equivalent experience in a scientific discipline or business administration
- Customer service focused mind-set with proven adaptability to work meticulously against timelines and pressure as well as to work independently with a flexible approach to problem solving
- Languages: English, fluent in written and spoken
- Enhancing operational excellence and delivering high quality regulatory dossiers to health authorities by leading teams of NIBR experts to ensure the timely delivery of the NIBR components for INDs and CTA submission dossiers
- Collaborating in cross-functional submission teams to develop and manage the timelines associated for NIBR components of regulatory dossiers
- Supporting senior team members with global marketing authorisation submissions
- Overseeing and managing the annual investigators brochure updates and ensuring teams receiving updates in a timely manner
- Contributing to bringing innovative novel therapies to patients as quick as possible
Location: Basel, Switzerland
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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