Regulatory Affairs Associate - 74248

Job Ref: J27955
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 08 August 2018
  • Middlesex, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

To work with the Clinical Trial Team Lead to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with internal processes and policies as they apply to the role.

Key Responsibilities:

  • Coordination of CTA Substantial Amendment submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with company policy and procedures.
  • Accountable to the Clinical Trial Team Lead for overall work plans.
  • Accountability for agreed tasks and projects.
  • Ensure independent communication, with a range of internal staff, in support achievement of the assigned goals.
  • Ensure compliance with company CTA and maintenance process through timely action and completion of records in internal systems.
  • Ensure quality of own work to agreed timeframes, including compliance with internal systems and record keeping.

Skills/Experience Required:

Basic qualifications:

Biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.

This role requires a good understanding of submission requirements for multiple countries/submission types and an ability to work in a matrix environment.

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 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.

07/09/2018 11:21:13