Associate Director Regulatory Affairs
Company: VirtualVocations
Location: Bridgeport
Posted on: November 17, 2024
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Job Description:
A company is looking for an Associate Director, Regulatory
Affairs and Submissions.
Key Responsibilities
Provide regulatory guidance to sponsors regarding drug development
and submission requirements
Lead the preparation and submission of regulatory documents,
including INDs and meeting requests
Collaborate with cross-functional teams to ensure high-quality
submissions and compliance with regulations
Required Qualifications and Education
MSc/MS or PhD in a relevant field
5+ years of US regulatory experience in an industry setting
Strong knowledge of drug development and regulatory policies,
particularly ICH, FDA, and Health Canada guidelines
Demonstrated experience with leading IND submissions in the US
Experience with Health Canada is an asset
Keywords: VirtualVocations, Newark , Associate Director Regulatory Affairs, Executive , Bridgeport, New Jersey
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