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Associate Director, Regulatory Affairs CMC

Company: Clinlinks
Location: Boston
Posted on: March 19, 2023

Job Description:

Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC Ref #: 369 Sector: Regulatory Affairs Type: Fixed This position is with a small (200 employees) and growing oncology/hematology company in Cambridge, MA. Along with recently filing a BLA, this company has multiple, late-phase, novel oncology molecules as well as an early phase I/O pipeline.

The regulatory team at this company is going to about double in size over the next 4 to 5 months. This Associate Director, Regulatory Affairs CMC will prepare global regulatory eCTD CMC submissions, identify supporting documents required for global CMC submissions, author CMC briefing documents for meetings with regulatory agencies, and more.

This company offers an excellent all-encompassing compensation package with base, bonus, stock, LTIs, and strong benefits. If interested in learning more, please apply today!

Keywords: Clinlinks, Boston , Associate Director, Regulatory Affairs CMC, Executive , Boston, Massachusetts

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