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GPRM/RegCMC Senior Manager

RM IT Professional Resources AG

Posted on Feb 4, 2021 by RM IT Professional Resources AG

Basel, Switzerland
Immediate Start
Annual Salary

GPRM/RegCMC Senior Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

  • Extensive work experience in Regulatory Affairs and drug development

  • Expertise with regulatory guidelines as well as practice with drug and biopharmaceuticals

  • Capability to critically evaluate data from a range of scientific disciplines along with computer literacy

  • Familiarity with regulations, guidelines and product life cycle maintenance is desired

  • Degree in a Science based discipline such as Chemistry, Pharmacy, Biochemistry, Biotechnology, or Biology

  • Languages: English, fluent in written and spoken

Your tasks:

  • Providing strategic and operational regulatory direction and supporting the DRA global program team representative and GTAL for programs through development, registration and approval

  • Ensuring the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team representative and GTAL

  • Reporting to the DRA GPT representative for the project and leading regional RA sub teams in order to ensure regulatory compliance for assigned projects

  • Implementing regulatory strategy and managing operational activities for assigned regions

  • Determining requirements and setting objectives for Health Authority interactions

  • Reviewing promotional and non-promotional materials and press releases and ensuring messages are consistent with the company's policies

  • Identifying issues, gaps, and trade-offs impacting optimal and timely submission and approval.

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.
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: 1082074855

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