Regulatory Affairs Manager

4 weeks ago

Uxbridge, United Kingdom i-Pharm Consulting Full time


Regulatory Affairs Manager CMC

Duration: 6 month Contract Inside IR35

Location: Uxbridge, 3 days on-site per week

Hourly Rate: £40-£55 per hour dependent on experience.

This role focuses on the critical aspect of Chemistry, Manufacturing, and Controls (CMC) within regulatory affairs. Responsibilities include:

  • Leading global regulatory strategies with a strong emphasis on CMC for multiple products.
  • Providing expertise in CMC regional issues, ensuring compliance with global filing plans.
  • Assessing fitness for CMC submissions and managing all related regulatory activities.
  • Authoring responses to regulatory inquiries and coordinating CMC submissions.
  • Collaborating with internal teams and affiliate offices on CMC strategies.
  • Communicating regional supply chain needs and launch requirements.
  • Guiding change control requests and setting project priorities with a focus on CMC.
  • Analyzing regulatory intelligence and sharing insights with stakeholders.
  • Keeping abreast of legislative and regulatory developments impacting products.

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