Manager CMC Regulatory Affairs

About the role

We are seeking a Manager CMC Regulatory Affairs to join our CMC Regulatory Affairs team. In this role, you will interpret the current, approved, and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process — supporting the review of documentation submitted to global health authorities to enable the release of lots to clinical trials.

What you'll do

• Interpret the current, approved, and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process — supporting the…
• Collaborate across cross-functional teams while managing a team of your own, ensuring submissions appropriately support the release of investigational product
• Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted to global health authorities to support the…
• Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs
• Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials

What you need

• 7–9 yrs of experience
• Regulatory affairs
• Clinical research
• Documentation
• Compensation and benefits
• Communication
• B.Sc or BA

Good to have

• Chemistry
• Biology