Compliance Scientist in Regulatory Affairs

On behalf of our client, an international biopharmaceutical company, Swisslinx is looking for a Compliance Scientist. In this role you will manage regulatory document lifecycles, oversee training and compliance activities, support audits and inspections, and perform various administrative and project-related tasks to ensure departmental effectiveness and regulatory adherence!

Contract type - 6 months
Start Date - ASAP
Location - Bern
Workload - 100%

YOUR MISSION:

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 including pre-inspection and related follow-up activities as needed
- Audit readiness activities including managing eStaff Record filing repository
- Support tracking of audits & inspections performed in GRA
- Support management of quality non-compliance events in GRA, such as deviations and CAPAs

Reporting and Analytics
- Preparation and/or review of various compliance reports
- Prospective monitoring of various compliance indicators

Other
- 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 and Distribution of compliance Newsletter

General
- 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

YOUR BACKGROUND:

• Excellent knowledge of English (MANDATORY) and German (ADVANTAGEOUS).
• 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 pharmaceutical industry. Biologics Regulatory experience preferred.
• 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
• Cultivates talent and hires/coaches effectively

WHAT'S ON OFFER

• An initially 6 month contract at an internationally-renowned biopharma company.
• A varied job in a dynamic but stable environment with the opportunity for professional development.
• A competitive salary.

If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.