CMC Regulatory Consultant

Location France
Discipline: Regulatory Affairs
Job type: Contract
Salary: ££100/hour
Contact name: Kimberley Warren

Contact email: kimberley.warren@rbwconsulting.com
Contact phone:
Job ref: 29171
Published: 15 days ago
Expiry date: 13 Oct 2023 11:59
CMC Regulatory Consultant
Remote Position
6 month contract
£100/hour

A leading pharmaceutical business is keen to secure a CMC Regulatory Consultant to lead and deliver post-approval activities across all global markets for a commercial biopharmaceutical asset. This will be a 6 month contract, that may be renewed.

Responsibilities:
  • Lead the CMC Regulatory strategy for all post-approval activities of the asset, providing advice and guidance to the technical team
  • Liaise with the Local Affiliates of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timeline
  • Represent CMC Regulatory across the relevant governance meetings and activitie
  • Write, review and compile (as needed) all regulatory documents in support of each submission on time and in line with country requirement
  • Generate gap analysis and risk management support for each submission as needed
 
 
Requirements:
  • Extensive experience in managing the delivery of post-approval CMC Regulatory activities for biopharmaceutical assets globally
  • Experience in delivering Marketing Applications globally
  • Degree in a relevant science/technical subject
  • Fluent in English

If this sounds like the ideal next contract for you please apply online.