Abhilash Ghanwat M. Pharm
- Role
- Manager Global Regulatory Affairs - Cmc Submission Management at Takeda
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Abhilash Ghanwat M. Pharm
As a highly skilled regulatory affairs professional with experience in the pharmaceutical…
Experience
Manager Global Regulatory Affairs - Cmc Submission Management
Apr 2023 — Present
The position drives the Global CMC Submissions Team for Development submissions such as IMPD/CTA/IND, Marketing Applications such as NDA, MAA, BLA, JNDA, and Post-Approval Changes. This role drives submissions by managing a team of subject matter experts including Pharmaceutical Sciences representatives, Quality representatives, and cross-functional stakeholders in Regulatory. Job responsibilities also involve establishing the document plan, authoring timeline negotiations, driving all deliverables against the timeline, compiling all submission-ready documents, and delivering the final submission components to the Publishing team. Where R&D deliverables are needed for commercial regulatory submissions, the Manager collaborates with the CSM Lead in Global Manufacturing and Supply (GSM) to prioritize documents, drives the timeline, and manage the R&D stakeholders. The role also ensures all deliverables are prioritized and tracked and delivered on time, escalates issues where they are identified, and provides strategic insight on issue resolution.
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.