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FDA Regulation Associate
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Full-time
- The ideal candidate will have broad work experience in counseling companies with FDregulated products, reviewing contracts, and supporting corporate deals involving such regulated companies, including risk assessment and regulatory compliance counseling with respect to the FDCA, Anti-Kickback Statute, Sunshine Act, state manufacturer/distributor laws, etc.
- A successful candidate will have the opportunity to provide FDA regulatory counseling to cutting-edge technology companies and support corporate and contracting teams in M&As, asset deals, IPOs, and other complex transactions.
- Our FDA regulatory group works with a broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
- Given the firm's nexus to companies with next-generation products and innovative technologies, we commonly help clients with Client medical technologies develop FDA regulatory strategies for seeking marketing authorizations, preparations for commercial launch, and regulatory compliance counseling for manufacturers/distributors post-approval/clearance.
- Candidates must have stellar academic credentials, excelling verbal, written and interpersonal skills.
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