Associate Director - Regulatory Affairs, CMC

August 3

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Description

• Reporting to the Senior Director, Regulatory Affairs & Global CMC Lead, the Associate Director, Regulatory Affairs-CMC will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. • This role is accountable for the planning and technical execution of the CMC regulatory strategy and for representing Regulatory Affairs-CMC in cross-functional teams and with external partners. • The successful candidate will have a strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and commercial (NDA/MAA) submissions.

Requirements

• Bachelor of Science degree in a field related to pharmaceutical sciences. • 6-8+ years of experience in Regulatory-CMC or within a CMC function (e.g. Analytical, Formulations, Process Chemistry, QA, QC) in the biotech/pharmaceutical industry with a focus on CMC for small molecules. • Experience with NDA submissions is required. • Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs. • Knowledge of current regulatory guidelines (FDA/ICH) pertaining to drug development, with particular emphasis on CMC/Quality. • Experience with review and/or providing content for CMC/Quality regulatory submissions, including IMPD and IND development/maintenance. • Experience with writing and leading NDA Module 3 sections is required.