Associate Director, Regulatory Affairs CMC

Senior Manager/Associate Director, Regulatory Affairs CMC

*Hybrid Role in Rockville, MD (roughly 2x per week onsite)*

Meet has partnered with a commercial-stage biotech that is looking for a Senior Manager or Associate Director of Regulatory Affairs CMC to join their team. Our client has several approved drugs in the rare disease space with a strong clinical development pipeline.

Key Responsibilities

• You will support Regulatory CMC lifecycle management for approved drugs
• You will be responsible for the hands-on authoring of a variety of technical documents (CMC sections of Module II and Module III submissions)
• You will work with cross-functional teams (CMC, Clinical Regulatory, Quality...) to support global submissions.

Key Qualifications

• 6 years of relevant experience in Regulatory CMC
• Small molecule background highly preferred, post-marketing experience preferred
• Experience working in smaller biotech environment preferred
• Ability to work a hybrid model in Rockville, MD (flexible)

Please reach out to Ryan Moran if you're interested in learning more:

✉: ryan.moran@meetlifesciences.com