At Acetylon Pharmaceuticals, we understand that our success in bringing important new drugs to patients depends on the extraordinary contributions of talented, experienced individuals who are dedicated to working together to achieve breakthrough therapies for critical human diseases. If you welcome taking on new challenge and appreciate working in a supportive, team-oriented environment, we strongly encourage you to consider a career with us.
The Regulatory Affairs Manager will partner with cross functional teams to plan and prepare Chemistry, Manufacturing and Control (CMC) and clinical development submissions regulatory submissions. This person will provide regulatory guidance and support to product development teams and contribute to strategy development. The Regulatory Affairs Manager will keep current in regard regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for regulatory affairs processes at Acetylon.
The candidate will be the lead physician for the hematologic malignancies program for Acetylon's first drug candidate, ricolinostat (ACY-1215), currently entering Phase 2 development in multiple myeloma. He/she will be responsible for medical monitoring of all heme malignancies clinical programs for ricolinostat including delivery of Phase 1b and Phase 2 data in multiple myeloma to support the upcoming Phase 3 program and for exploratory studies in other hematologic cancers. In addition, the candidate will contribute to ongoing strategic development of the ricolinostat clinical program including the Phase 3 development program and including regulatory presentations and publications in conjunction with the VP Clinical Development and other members of the Acetylon team.
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