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Assistant General Counsel, Fda Regulatory Compliance
Refer job# DBEC169693
Assistant General Counsel, FDA Regulatory Compliance Responsibilities: Provide legal support in managing the OTC private label business, including SOPs, investigations, vendor qualification and compliance. Provide legal support for FDA audits and inspections and responses to FDA audits and inspections. Provide legal support for FDA recalls, including reporting of adverse events and consumer complaints. Provide legal support for FDA products, including proper storage, labeling and compliance./ Assist with procuring the release of customs detained FDA product. Assist with training on FDA regulatory compliance. Assist the business with FSVP compliance. Lead engagement with FDA and remain current on new regulations and regulatory trends. Provide general legal support on other merchandise regulatory issues.

Qualifications: Doctoral Degree (DBA / JD / MD / PhD) or equivalent. Bar membership with at least one state and in good standing. Retail experience is preferred. Should have 5-10 years of relevant experience. Experience with FDA regulatory matters as main responsibility either at the FDA, at a law firm, or in-house. Intermediate to an advanced working knowledge of Microsoft Office desktop applications, inclusive of Excel, Access, Word, PowerPoint and Outlook. Exposure to web-based applications including web forms, portals and workflow tools. Excellent communication skills are critical to the job function- communicating with and building relationships with internal business partners, vendors, outside counsel and government officials. Part of this communication is imploring good judgment. Strong analytics, problem-solving, multi-tasking and prioritization capabilities.

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