The CMC Regulatory Affairs Specialist is responsible for for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact.

E ssential Duties and Responsibilities include, but are not limited to, the following :

• Plans and conducts critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, and supplements to ensure a high quality regulatory submission and approval.
• Reviews Change Controls by cross-checking the description in regulatory filings in INDs / IMPDs, CTAs and BLAs / MAAs and ensures that CMC related changes are reported to competent authorities in accordance with regulatory requirements, as necessary.
• Tracks and / or completes CMC regulatory commitments for INDs / IMPDs, CTAs, and BLAs / MAAs.
• Provides CMC-related mentorship to IOPS so that their short-term and long-term goals are achieved on time and with highest quality.
• Participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests.

E ducation and Experience :

• Requires BS / BA in Chemistry, Biology or related field (advanced degree preferred).
• 2 years of experience working in the biopharmaceutical manufacturing or related industry including experience in regulatory or compliance related activities.
5 hours ago