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Regulatory Submission Publisher

RM IT Professional Resources AG

Posted on May 2, 2021 by RM IT Professional Resources AG

Basel, Switzerland
Immediate Start
Annual Salary

Regulatory Submission Publisher vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

  • 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

Your tasks:

  • 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

Start: 06/2021
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH16899

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.

Going the Extra Mile.

As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.

Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

  • All administrative questions

  • Finding an apartment

  • Health - and social insurance

  • Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Reference: 1186444805

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