Must have: Bachelor's degree (or higher) in chemistry, pharmaceutical sciences, or related fieldPrior experience authoring CMC sections for regulatory submissions (IND, NDA, BLA, or MAA)Experience with both US-FDA and EU (IMPD/MAA) regulatory submissionsStrong knowledge of FDA, EMA, and ICH CMC regulatory requirementsAbility to write and review documents in eCTD formatExperience collaborating with cross-functional teams (e. g.
, regulatory affairs, manufacturing, scientists)Experience with Investigator Brochures, Briefing Documents, DSUR/AR/RTQ submissions, and responses to health authoritiesStrong technical writing and documentation skills for regulatory submissionsProven ability to follow regulatory templates and guidelinesAbility to identify and escalate CMC regulatory risksNice to have: Project management
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