Regulatory CMC Lead

Main Responsibilities:

Lead preparation and filing of regulatory CMC section of assigned IND, CTA and NDA submissions and manage the interactions with FDA, EMA and other authorities for CMC topics. Provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory CMC requirements are considered and appropriately incorporated into clinical and commercial products. Ensure Ascentage’s CMC is cGMP and ICH guidance compliance. Assess CMC planned changes during development and provide guidance to CMC and report to health authorities as appropriate. Function as RA CMC representative in development project team. Might lead FDA meetings on CMC issues.

Minimum Requirements:

• BS in Life Sciences or Chemistry required; advanced degree highly preferred
• 7+ years of pharmaceutical or biotech industry experience
• 5+ years of hands-on regulatory affairs CMC experience
• Experience in authoring and reviewing eCTD CMC documents for small molecule innovative drugs
• Experience in regulatory CMC for early and late development projects
• Experience with FDA inspection and internal audit
• Experience with FDA is essential and global experience is highly preferred