Job Description
Our client is looking for a Regulatory SME who has interfaced with the FDA and DEA thoroughly. They are assisting a CMO and neither parties have a true Regulatory department. The CMO will be manufacturing controlled substances (ADHD) and they are currently finalizing the budget and they have already secured the building. They need this SME on retainer for when they have questions regarding their documentation and compliance, so extensive understanding of regulations for the FDA and DEA is nonnegotiable. The first is their submissions for nutraceuticals (planning for Feb/March timeframe to submit) and then pharmaceutical with DEA products. This SME will be reviewing the documentation needed for submission and working on the dashboard on the FDA/DEA website for electronic submissions. Essentially anyone who has acted as a DEA liaison for a pharma company would be ideal and know how to do the reconciliation and know what they typically do for annual audits for material movements. They currently have 3 vaults on the site selected, so if they are modifying a vault, they want this SME to tell them what the DEA would want/expect to see. They would like for this person to have familiarity dealing with CMO’s. The CMO does not plan on filing their own drug, only manufacturing for other companies.
Remote: Regulatory SME (FDA/DEA) (232425)
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