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The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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Associate Director Level: Minimum of 7 years in the pharmaceutical industry, with at least 4 years dedicated to regulatory labeling. Contribute to or lead strategic initiatives, ensuring compliance and alignment with global regulatory requirements.
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Liaises with clinical and regulatory associates and the Leica Biosystems legal department to support execution of legal agreements by leveraging the contract management system to enter supplier information and upload agreements.
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Experience 7-10 years pharmaceutical industry experience, including 3 years of experience in CMC Regulatory Affairs projects comprising biologic therapeutics. · Represents Regulatory Affairs activities among cross-functional project teams and functions as the primary contact on CMC regulatory aspects of the projects between Akston and its partner companies.
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IVD Regulatory Affairs or Quality Assurance experience is very beneficial and highly desirable. Completes a variety of administrative tasks for Regulatory project support which may include but is not limited to document formatting, document generation, document storage co-ordination and shipping of regulatory submissions.
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