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Regulatory Affairs CMC Coordinator - Geneva

OM Pharma — Geneve
29.03. | Employee | 100%

Regulatory Affairs CMC Coordinator - Geneva

We are looking for a Regulatory Affairs CMC Manager for our OM Pharma site in Geneva to coordinate CMC activities for our products. You will report to the Regulatory Excellence Centre team lead and your responsibilities will include, but not be limited to:
  • Define and drive CMC regulatory strategy for technical projects (marketed products, chemical and biological origin), conduct risk assessments and set-up mitigation plans
  • Identify required content to ensure compliance with regulatory standards and review CMC documents from technical departments
  • Author and review high-quality CMC documents in the frame of renewals, variations and life cycle management activities
  • Liaise with Regulatory managers in charge of products and geographic regions, and Regulatory Operations groups to ensure appropriate planning and timely preparation of CMC-related submissions
  • Manage answers to questions from Health Authorities related to CMC topics
  • Coordinate assessment of worldwide impact of proposed manufacturing changes, ensure the regulatory implications have been considered and provide regulatory strategy for optimal and timely implementation of these changes
  • Provide required support to audits/inspections from partners and Health Authorities
  • Represent Regulatory CMC in cross-functional project teams
  • Provide guidance and mentor junior staff
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criteria:
  • University degree in Scientific area
  • At least 7 years of work experience in Regulatory Affairs CMC, with proven expertise in Biologics
  • 2 years' experience in team management
  • Good knowledge and appropriate interpretation of guidelines, directives etc…
  • Experience in projects management : strategic thinking and acting, entrepreneurship skills
  • Leadership qualities, diplomacy and respectful behavior
  • Strong adaptability, excellent communication and negotiation skills
  • Fluent in English and French both in oral and written conversation
You describe yourself as a solution oriented and flexible person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines.

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