Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have (Fully Remote)

Jobgether; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Jobgether is seeking a senior regulatory affairs professional with deep CMC expertise focused on small-molecule products. You will interpret North American regulatory guidelines and support product lifecycle activities, including reporting and surveillance, ensuring compliance across development and commercial stages.

You will collaborate with cross-functional teams in an international environment, applying drug development knowledge to complex regulatory needs and guiding documentation,

Job description

• Provide senior-level regulatory CMC expertise for small-molecule products, focusing on Chemistry, Manufacturing, and Controls (CMC) compliance.
• Interpret North American regulatory guidelines and support product lifecycle activities, including reporting and surveillance.
• Collaborate with cross-functional teams in an international environment, applying drug development knowledge to complex regulatory needs.