The Life Science Career Network – CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services.

For our client, an International Pharmaceutical/Biotech company located in Bern, Switzerland, we are looking for a

Compliance Scientist Regulatory Affairs (6078)

in a 6 months contracting role, extension possible.

Activities include:

Procedural documents management

  • Support procedural document preparation/review and lifecycle management
  • Ensure compliance of GRA with local and global procedural documents
  • Maintenance of the company online glossary with GRA definitions

Training

  • Training analysis and assignment, Maintenance of training presentations
  • Onboarding newcomers to the department
  • Facilitate classroom training sessions
  • Support annual reviews of training curricula

Compliance activities

  • Support regulatory agency inspections and audits incl. pre-inspection and related follow-up activities
  • Audit readiness activities incl. managing eStaff Record filing repository
  • Support tracking of audits & inspections performed in GRA
  • Support management of quality non-compliance events in GRA (eg deviations, CAPAs)

Reporting and Analytics

  • Preparation and/or review of various compliance reports
  •  rospective monitoring of various compliance indicators

  • Management of the group inbox, Project support activities as required
  • Administrative activities such as scheduling meetings and meeting minutes
  • Updates to SharePoint sites, Meeting attendance, Preparation, Review/Distribution of compliance Newsletter

Requirements    

  • Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD,MD) or Business (MBA) an advantage.
  • 1+ years regulatory experience in the pharma. Biologics Regulatory experience preferred.
  • English must, German nice to have

  • Thinks beyond and maintains an external and strategic focus
  • Builds bridges and helps teams develop collaboration
  • Unleashes outcomes and creates an accountable work environment
  • Ignites agility and instills personal flexibility in self and teams
  • Inspires the future and ensures clarity around the strategy

  • Applies practical knowledge of job area typically obtained through advanced education and work experience
  • Works independently with general supervision to achieve operational targets with direct impact on departmental results
  • Problems faced are difficult but typically not complex, sometimes requiring understanding of broader set of issues
  • May influence others within the job area through explanation of facts, policies, and practices
  • Select jobs may have formal supervisory responsibilities for support employees

Interested? Contact us!

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