Regulatory Affairs Associate

Job Ref: J27056
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 11 June 2018
  • Maidenhead, Berkshire, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

The Regulatory Associate is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.

Key Responsibilities:

  • Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trials notifications etc.
  • Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
  • Review of and input on documents related to clinical trial submissions managed by other stakeholders such as DSUR, IB, Protocols.
  • Ensure approved company CTA processes are followed within agreed timelines.
  • Monitor key project milestones and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
  • Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
  • Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met.
  • Provide operational/administrative support for the Clinical Trials Regulatory Group
  • Participate in process improvement initiatives within CTRG and cross-functionally.
  • Support SOP reviews and updates when required.

Skills/Experience Required:

Education

  • Life Sciences Degree qualified.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
11/07/2018 10:35:50
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