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Regulatory Affairs Manager-Emerging Markets

  • Job reference: 927433
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 04/09/2019

Hello all. I am currently seeking a Regulatory Affairs Manager-Emerging Markets for an initial 12-month contract with our client in the Cambridgeshire area. Please contact me at Andreia.Terron@orioneng.com for more details

Regulatory Affairs Manager-Emerging Markets

Description: To lead regulatory projects for emerging markets commercialisation and life cycle management of assigned products. The role is multi-regional.

Primarily responsible for Regulatory Affairs Manager-Emerging Markets activities, which may include any/all of the following:

  • Responsible for the development of regional strategy and execution of the preparation of CMC components of filings for one or more products
  • Responsible for organization and preparation CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of annual reports (Canada Annual Notification, Brazil HMP), GMP registration of facilities, and providing guidance on regional regulatory mechanisms to optimize product registration including expertise on regional regulatory requirements and precedence to cross functional teams


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