Regulatory CMC Manager

1 week ago


Ledston, United Kingdom Rbw Consulting Full time

As a Regulatory CMC Manager - Oncology, you will play a key role in ensuring compliance with regulatory requirements for our clients' small molecule oncology products.

Your responsibilities will include managing CMC regulatory activities for clinical programs, authoring documents for INDs and IMPDs, responding to Health Authorities, and preparing QP release documents.

You will also collaborate with external CMOs and manage post-submission activities.

We are looking for someone with over 10 years of experience in CMC technical roles, with at least 5 years in lifecycle management of small molecule products.

The estimated salary for this position is around $120,000 - $150,000 per year, depending on location and experience.



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