Biosimilars Regulatory Project and Submission Specialist

Vor 5 Tagen

Eysins, Schweiz Fresenius Vollzeit

Job Summary

Functional Goal:

  • Leads and contributes to the design, development, maintenance and improvement of all processes, activities and systems contributing to the successful and timely submission of dossiers.

Main Tasks:

  • Under supervision take ownership of the operations tasks for submissions up to their submission to the HA.

  • Participate actively in the coordination of the planning and management of submission related documents, regulatory data and archiving for Biosimilars.

  • In close collaboration with stakeholders, support strategies to implement technologies and data governance supporting all current and future authorities' requirements and ensures consistency of standards in systems and processes across relevant global company and Biosimilar functions.

  • Verify that resource and timelines assigned to project are in line with function capabilities.

  • On occasions participate in the implementation of Regulatory IT projects.

  • Follow-up costs to help control the best use of the budget of the Regulatory Information and Document Management activities for Biosimilars.

  • Be trained on requested SOPs and IT systems

  • Clean and format documents to make them eSubmission ready.

  • Train the organization on critical processes and techniques.

Other Tasks:

  • Follow-up and self-train on new guidance, standards developments and technologies.

  • Coordinate and be accountable for planning, tracking and on-time production of Biosimilars dossiers.

  • Under supervision Support submissions up to their dispatch with a goal of no rework needed.

  • Manage process for creation and update of Submission Compilation Plan (SCP) including collection of resources and timelines constraints for small submissions

  • Support the Biosimilar Data Governance to ensure data protection and consistency of key data and metadata across systems for Regulatory processes

COOPERATION

  • Create and maintain strong collaboration with cross-functional project teams

  • Support and promote the finalization of operational tasks when required for the best of the projects

  • Ensure that user support is provided within and outside of Regulatory Affairs, as appropriate.

  • Support submission team members in getting fluent in the use of agreed process or tools/systems.

Education:

  • Project Management  

  • Technology

  • Health Sciences

Job Specific Competencies & Skills:

  • Excellent organizational skills, work independently, self-motivated and proactive

  • Autonomous, goal-oriented and pragmatic

  • Strong customer-orientation and communication skills

  • Excellent analytical and problem-solving skills, Detail Oriented

Languages:

  • Fluent command of spoken and written English, French is a plus

Salary:

  • No university paper : 18'000 CHF / year (13th month included)

  • Bachelor degree : 30'000 CHF / year (13th month included) : - After 12 months salary increase to - 48'000 CHF / year (13th month included)

  • Master degree 42'000 CHF / year (13th month included) : After 12 months salary increase to 5'000 CHF - If PhD degree obtained increase to 5'000 CHF

  • Master/PhD + limited work experience : 60'000 CHF / year (13th month included)

Benefits :

  • Fairmove/Transportation allowance: 125 CHF/month and up to 340 CHF (upon proof)

  • Swibeco/Meal allowance: 135 CHF/month (100%)

  • 20 days annual leave / 40 hours/week

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