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To meet accelerating growth, Enkrisi is seeking a leader to provide oversight of CMC regulatory strategy and investigational and marketing applications. The firm serves the needs of emerging biotech in the US, most of whom do not yet have major products approved and on the market. The firm advocates CMC strategy directs CMC Operations and develops CMC submission content that represents the best interests of biotech, focusing on the critical issues affecting smaller emergent companies and building programs to enhance their development.
The ideal candidate will serve as the CMC regulatory subject matter expert for the firm and must be willing and able to be “hands-on” by rolling up sleeves and being detail-oriented, providing independent or team submission authoring.
The ideal Candidate has well-developed and demonstrable writing skills, understands strategic communications, and with the ability to “simplify the complex.” Strategic/critical thinking skills, as well as initiative, are a must for this role! Additional skills needed include a sense of urgency (milestone/timeline driven) and the ability to ask questions and probe further.