Jody Roth
Sr. Vice President Global Regulatory Affairs and Medical Writing
- Role
- Sr Vice President Global Regulatory Affairs and Medical Writing at Immunovant
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Jody Roth
Experienced regulatory advisor with over 25 years in drug development from Phase 1 to post-marketing of both large and small molecules. • Led two global development teams through the initial development and subsequent indications for autoimmune and oncology drugs. • Developed and coordinated global regulatory strategies supporting US (FDA), EU (EMA), Japan (PMDA), Canada (Health Canada) and China (sFDA).• Provided regulatory intelligence and strategy to new therapeutic areas to aid in the development of an innovative label.• Facilitated the approval of Oncology drug that was granted the following designations by FDA (fast track, breakthrough status and priority review). Skillsets: global regulatory strategy, patient reported outcome strategies, pediatric strategy, INDs, BLAs, NDAs, label negotiations, writing of INDs, BLAs and NDAs, FDA liaison for facilitation of communications.
Experience
Sr Vice President Global Regulatory Affairs and Medical Writing
Jan 2024 — Present
Education
Purdue University
Master's degree, Animal Sciences
1988 — 1994
Skills
- Pharmaceutical Industry
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.