Syed Anas
Regulatory Affairs Professional
- Role
- Senior Global Regulatory Affairs Specialist at CGI
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Syed Anas
With over 10.6 years of experience in Regulatory Submission Management and Operations, I…
Experience
Senior Global Regulatory Affairs Specialist
May 2024 — Present · Hyderabad, IN
Manages multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g, NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.]. Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions. Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows. Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals. Collaborates with cross functional groups across the organization and contributes to operational activities and ongoing initiatives. Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs.Assesses publishing resource and support needs and develops/implements solutions to create efficiencies. Organizes/ leads and facilitates and or participates in meetings with internal and external stakeholders (including acquisitions and divestiture efforts).
Education
Nagarajuna public school
Bachelor of Pharmacy - BPharm
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