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Regulatory Affairs Manager

Job Reference:
36413CXJ
Recruiter Name:
Parkside Recruitment
Job Type:
Operations
Salary:
£400 to £500 per day
Benefits:
Day Rate
Locations:
England
Contract Type:
Contract
Date Posted:
07/08/2019

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12 month Contract for a Regulatory Affairs Manager - CMC

I have an opportunity for an experienced Regulatory Affairs Manager to join a company who sole purpose is to improve the lives of their patients.
Built on a culture of excellence, commitment and passion my client is seeking a like mind candidate who is truly seeking an opportunity to do their best work .

Duties

* Coordinate the preparation of CMC documents to support the reg submissions in International regions (Asia, Latin America, Middle East, Europe and Africa)

* Work with pharma development manufacturing, Q and A external partners to deliver CMC components

* Coordination of responses to CMC questions from regulatory authorities

* Maintain and up to date awareness of CMC reg requirements

Skills

* You must have previous experience within regulatory affairs and extensive knowledge of reg requirements including ICH requirments and regional requirements

* Preparation of CMC regulatory dossiers and ongoing maintenance of licenses

* Competent with regulatory documentation and submission management systems

* Manage projects and tight deadlines

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.

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