regulatory expert in Schaffhausen

schaffhausen, schaffhausen
life sciences
job type
reference number
charlotte de keersmaecker, zürich professionals it
058 201 56 40
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job description

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 
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