Regulatory Compliance Specialist

 — Lausanne
15.02. | Employee | 100%

Regulatory Compliance Specialist

URGENT - Regulatory Compliance Expert - Contractor
we are recruiting, on behalf of our client, 2 regulatory compliance experts with experience in the pharmaceutical industry.
This position is a temporary contract.
Responsiblities

  • Responsible for planning the site's regulatory activities for the products under his/her responsibility and for new developments projects. Collaborate with Central Regulatory on the establishement of planned activities (variations, renewals,...) and prioritization. Escalate potential issues or delays
  • Ensure timely availability of documentation for planned regulatory submissions and RTQ, act as facilitator between Central Regulatory and plant technical functions (production, technical and analytical/stability departments) and collaborate with worldwide affiliates for regulatory compliance matters
  • Evaluate regulatory relevance of proposed changes. Participate in change control process from creation, strategy and implementation until closure, represent regulatory point of view at the site's Change Control Committee
  • Identify and evaluate gaps as well as propose regulatory remediation and get escalation process under way in case of non-compliance
  • Regulatory Compliance SME during audits and Health Authorities Inspections
  • Elaborate SOP and WI for all processes related to team activities and daily tasks
  • Evaluate Regulatory Compliance resources and budget for projects
  • Coordinate ways of working with other departements and work on process improvement
  • Onboard newcomers in team, provide training and supervision
Profile
  • Master in Life Sciences or equivalent
  • 5-7+ year in a Pharmaceutical Quality Environment
  • Good experience in Regulatory Affairs/CMC Understanding of laboratory techniques
  • Good understanding of GMP
  • French: fluent (oral and written)
  • English: fluent (oral and written)
  • MS Office: good command
  • M-ERP, Veeva, TrackWise, DIGA: good knowledge
  • Team player, ability to analyse and attentive to details, good communication and influencing skills, handling of priorities, adaptability
Contact
Spring Professional Life Science: 0041 58 233 40 20

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