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Regulatory Site Officer

Job title: Regulatory Site Officer
Contract Type: Contract
Location: Suffolk, England
Industry:
Salary: Competitive
Reference: BH-96744
Contact Name: Syeda Islam
Phone Number: 0161 942 4000
Job Published: 17 days ago

Job Description

Regulatory Site Officer – Contract – 12 Months - Suffolk


An exciting new opportunity is available with a global pharmaceutical company to join their regulatory affairs department. The purpose of this role is to oversee all tasks associated with cGMP regulatory reports and protocols.

Key Responsibilities - Regulatory Site Officer
  • Review and evaluation of all CMC related activity within regulatory affairs establishing strategy and protocols for continued efficiency in processes
  • Ensure any changes in legislation and regulation is applied correctly for site compliance
  • Analyse any complex regulatory issues and processes to identify risks effecting site compliance and provide appropriate solutions accordingly
  • Deep technical understanding of site GMP documentation, ensuring relevant regulatory body guidelines have been followed and documented accordingly for product approval
  • On occasion provide professional advice to site and third party manufacturing partners
  • Be responsible for information to support internal and external inspections/audits
  • Act as a technical expert, give regulatory advice to other departments and support junior members of staff where necessary.
Key Requirements - Regulatory Site Officer
  • Minimum degree qualification in a relevant life sciences subject
  • Very good understanding of CTD Module 3 Content and regulatory CMC  
  • Knowledge and experience applying regulatory legislation to ensure site compliancy
  • Demonstrated experience working with quality management systems (Documentum) and cGMP
  • Deep technical understanding of drug development process and compliance required for registration
  • Understanding of global regulatory process and being aware of all proposed changes that can affect the product responsible
  • Very good written and spoken communication skills
  • Good interpersonal skills in order to maintain good relationship with all teams responsible domestically and internationally
  • Able to make decisions to positively impact all aspects of the regulatory process
  • Be highly organised and ensure all deadlines are met while maintain high quality at all times

This is a contract role and to be considered candidates must be eligible to work in the UK. If successful you can expect a competitive salary package as well as the opportunity to join a world leader in global pharma.

Please contact Syeda Afsana Islam on 0161 942 4060 for more information on rates and applying.

Regulatory Site Officer – Contract – 12 Months - Suffolk