26 days ago on proclinical.com

CH - Regulatory Expert - Normal

ProClinical AG

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CH - Regulatory Expert - Normal

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A leading multinational pharmaceutical, and medical devices company currently have an attractive job vacancy available for a CH Regulatory Expert to be based in their office in Schaffhausen, Switzerland. 

Key Responsibilities:

As a CH Regulatory Expert, you will perform and support the following activities to ensure regulatory filing compliance as a basis to support the business for APIs manufactured:

  • 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
  • Sunrise project: Regulatory actions, e.g. customer communication, filing renewals, filing transfers, filing withdrawals
  • 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
  • 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
  • Ensure regulatory filing compliance and continued lifecycle management
  • Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities for Janssen Supply Chain (JSC) products manufactured in Schaffhausen

Qualification and Experience:

  • A minimum of a Bachelor's degree 
  • 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. 
  • A demonstrated ability to communicate regulatory requirements is required. 
  • Communicates cross-functionally and cross-company as well and presents and defends regulatory strategy and opinion to project teams. 
  • Knowledge in German is preferred but not absolutely required

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Latifah Khan on 0203 8234 367 or upload your CV on our website www.proclinical.com. A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.