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Manager, Regulatory Affairs

Location: MD
Industry: Pharmaceutical/Biotech
Job Code: 12024-04

Responsibilities:

• Facilitate regulatory strategy development and implementation for Product Development Teams, take the lead on regulatory submissions for product and provide authoring, review, and coordination for quality submissions to regulatory agencies.
• Prepare for meetings, teleconferences, and other communications with FDA (including read-ahead packages and/or other necessary documentations), educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
• Serve as the regulatory representative on Product Development Teams and provide regulatory support and advice for the teams.

Requirements:

• 5+ years of industry experience in Regulatory Affairs for products in advanced development (IND to BLA). Regulatory affairs experience in biologics.
• Advanced Degree (MS or Ph. D preferred) in a Biological Science.

Contact:

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