REGULATORY AFFAIRS

WORK PRODUCT​

Develop a Regulatory Strategy and Plan  

Produce, QC and File documents for Pre-IND/Pre-Submission

Conduct Pre-IND or Pre-Sub Meeting, Produce Minutes

Review, QC, and File Regulatory Submission

Lead FDA or equivalent Regulatory Body Interactions and Activities

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Provide On-going Regulatory Support 

• Attend team meetings 

• Advice on regulatory topics

• Attend meetings with Pharma partners

• Produce regulatory materials for investor or business development presentations

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