Small Molecule Oncology Product Manager

1 week ago


Ledston, United Kingdom Rbw Consulting Full time

R BW Consulting is seeking a talented Regulatory CMC Project Manager to lead our regulatory activities for small molecule oncology products globally. This is an exciting opportunity to work independently and collaborate with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.

The ideal candidate will have over 10 years of experience in CMC technical roles, with at least 5 years in lifecycle management of small molecule products. They should have a strong understanding of IND/NDA and IMPD/MAA formats, as well as knowledge of drug substance and product CMC.

  • Key Responsibilities:
  • Manage CMC regulatory activities for clinical programs
  • Author documents for INDs and IMPDs, respond to Health Authorities, and prepare QP release documents
  • Collaborate with external CMOs and manage post-submission activities
  • Requirements:
  • Degree in Pharmacy or a relevant science/technical subject
  • Proficient in English, French is an advantage
  • Organized, independent, and able to manage multiple activities

The salary range for this position is $130,000 - $170,000 per year, depending on experience.



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