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CMC Regulatory Associate - Switzerland  

Ferring Pharmaceuticals (company)


Posted on : 20 March 2017

Project Description


 About Us 
  • The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics. 
  • Our company has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.


Role
Ensure right first time submissions, decreasing implementation lead-times (e.g. time to market). Contribute to CMC regulatory compliance of operations. 



 Main Responsibilities  
  •  Draft and/or update CTD quality documents during product life-cycle (registrations in new markets, variations, line extensions, license renewals..).
  • Review CTD quality documents prepared by R&D and Product Supply/Manufacturing sites
  • Provide advice/input to project meetings related to regulatory technical requirements in cooperation with Global Regulatory Affairs (GRA)
  • Support GRA and the CMC regulatory colleagues in Product Supply with the external CMC Regulatory Surveillance activity
  • Supports sites with the regulatory workload of Third Party Manufacturers
  • Help GRA and manufacturing sites to answer to technical questions raised by regulatory agencies during product registration procedures



Required Experience & Skills 
  • Scientific degree (pharmacy, chemistry, biology or equivalent)
  • Significant practice (+5 years) of the registration procedures for new applications, variations, line extensions and transfers of pharmaceutical products.
  • Significant practice (+5 years) of CTD scientific writing (CMC) in English for EU, US, JP and RoW countries.
  • Good knowledge of manufacturing process and control methods for pharmaceutical products.
  • Excellent knowledge and ability to interpret ICH regulatory guidelines.
  • Good knowledge of the pharmaceutical GMP environment including Change Management.
  • Oriented to regulatory compliance. Ability to write in a concise way. 
  • Organised and able to handle several tasks simultaneously and accurately. 



Analytical skills.
Interpersonal skills, team worker. 


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