Job Responsibilities: Direct and coordinate activities of assigned products within Regulatory Affairs encompassing developmental products and post-marketing commitments. Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy to ex-US strategy and filings. Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications. Provide regulatory guidance to team during the course of strategy formulation and submission preparation. Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to FDA standards for all regulatory submissions. #btn_share_social{ background: none !important; border-color: transparent !important; } Search for More Jobs Forward job
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