15 days ago
Role: Regulatory Affairs, CMC Lead
Our client is a biopharma organization with an exciting pipeline of Oncology indications. Currently with 11 INDs out and an NDA due to be filed this year. This client is looking to build their regulatory affairs division with a strong Associate Director or Director level professional, with experience with global IND and NDA filings. Reporting directly to the SVP Regulatory Affairs, the successful candidate will be expected to be comfortable working in a fast-paced, biotech environment.
- 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 global health authorities as appropriate.
- Function as RA CMC lead in development project team.
- Responsible for leading FDA meetings on Regulation CMC topics.
- BS in Life Sciences or Chemistry required; advanced degree highly preferred
- 10+ years of pharmaceutical or biotech industry experience
- 7+ 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