Associate Director, Regulatory Affairs CMC
Company: Clinlinks
Location: Boston
Posted on: March 19, 2023
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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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