A company is looking for an Associate Director, Regulatory Affairs and Submissions.Key ResponsibilitiesProvide regulatory guidance to sponsors regarding drug development and submission requirementsLead the preparation and submission of regulatory documents, including INDs and meeting requestsCollaborate with cross-functional teams to ensure high-quality submissions and compliance with regulationsRequired Qualifications and EducationMSc / MS or PhD in a relevant field5+ years of US regulatory experience in an industry settingStrong knowledge of drug development and regulatory policies, particularly ICH, FDA, and Health Canada guidelinesDemonstrated experience with leading IND submissions in the USExperience with Health Canada is an asset
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A company is looking for an Associate Director, Regulatory Affairs and Submissions. ...
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