Regulatory Affairs

Job Ref: J24575
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 01 December 2017
  • Surrey, England, UK
  • Competitive
  • Natasha Rollason

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The role:

Performance of pre and post approval regulatory activities to ensure compliance with the Falsified Medicines Directive.

Key Responsibilities:

  • Preparation and submission of MA variations, Article 61(3) applications and Change of Ownership applications.
  • Process and have clear communication of regulatory approvals to internal and external stakeholders.
  • Create, review and approve artwork texts and mock-ups.
  • To plan and track manufacturing site readiness and associated regulatory activities in collaboration with local FMD project manager.
  • Generation of status update reports concerning local FMD readiness.
  • Maintenance of regulatory archives and version controlling.
  • Work in accordance with Global and local Working Instructions and SOPs.
  • Carry out other activities which contribute to the effective performance of the Regulatory Affairs Department.

Skills/Experience:

  • BSc in Life Sciences
  • Experience in Regulatory Affairs within a Generic or Pharma business.
  • Ability to be flexible and multi-task within a fast-paced environment.
  • Experience in project management.

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.