Regulatory Expert in Schaffhausen

Schaffhausen, Schaffhausen
Life Sciences
Charlotte de Keersmaecker, Zürich Professionals IT
058 201 56 40
Jetzt bewerben


Regulatory Affairs Specialist Dear Regulatory Affairs Specialist, I'm on the hunt for a regulatory affairs specialist to join my international pharmaceutical client in Schaffhausen until March 2017 with a possibility for extension.
In this regulatory function located in Schaffhausen you will perform and support the following activities to ensure regulatory filing compliance as a basis to support the business for APIs manufactured:
  • Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions:
  • Coordination and preparation for new submissions, regular updates, variations, renewals
  • Customer communication (prior and after submission of regulatory filings and/or filing updates filing)
  • Collaboration with customers to develop and align regulatory filing strategies and implementation plans
  • Coordination and preparation of responses to deficiency letters or authority requests
  • Coordination and preparation of responses of customer requests related to filings and or other regulatory/technical questions or questionnaires
  • Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.)
  • Regulatory assessments of Change Requests and development of regulatory implementation plan
  • Regulatory assessment of major Non Conformances
  • Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
  • Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
  • Regulatory support for inspections and audits
  • Ensure regulatory filing compliance and continued lifecycle management
  • A minimum of a Bachelor's degree with a minimum of 6+ years of relevant experience in a highly regulated environment (preferably pharmaceutical industry) or an advanced degree (MS, PhD, etc.) with a minimum of 4+ years of experience is required.  
  • Regulatory CMC or CMC experience is preferred.
  • Good knowledge of English.  
  • Basic knowledge of regulatory requirements is preferred.  
  • Drug development experience is preferred.
  • A working knowledge of global HA laws, regulations, and guidance is required.  
  • Experience developing regulatory strategies and an understanding of product development is preferred.  
  • Solid understanding of chemistry relevant is preferred.  
  • Knowledge in German is preferred but not absolutely required
  If you're up for a new role and fulfill the requirements, click on the apply button!  I look forward hearing from you 
Jetzt bewerben