Sneha K.
Assistant Manager - Regulatory Affairs at Abbott
- Role
- Assistant Manager - Regulatory Affairs (Lcm) at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sneha K.
12+ Years of Experience with core expertise in Global Regulatory Labelling and Life-cycle…
Experience
Assistant Manager - Regulatory Affairs (Lcm)
Nov 2022 — Present · Mumbai, IN
Responsible for creating, maintaining & disseminating Company Core Data SheetsWork closely with Product Leads, SMEs and cross-functional teams to make available supporting documentation for submitting labelling variations.Assess & approve local labelling change requests.Interact with cross-functional stakeholders & provide global support to respond to deficiency letters and HA queries in a timely manner.Provide strategic and dossier support for license renewals, geo-expansions, indication expansions and routine license maintenance activities. Review and approve scientific & promotional materials Provide inputs on PSURs, ACO and coordinate RA information in RMPs. Responsible for maintaining EU licenses (submitting safety variations, license renewals, sunset clause extensions and PSURs)Create and disseminate DHPC packages, as required.
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