Brahmam Kapalavavi
- Role
- Regulatory Lead at Pfizer
- Location
- Greenville, NC, US
- LinkedIn followers
- 500 followers
About Brahmam Kapalavavi
Seeking a Principal Scientist position that will provide an opportunity to make a strong…
Experience
Regulatory Lead
May 2022 — Present
Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:\\\\n\\\\nDevelop, execute and maintain submission delivery plans, submission content plans, support operational and compliance activities for assigned deliverables and proactively provide status updates to designated stakeholders.\\\\n\\\\nLead and / or contribute to the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.\\\\n\\\\nContribute to Submission delivery strategy\\\\n\\\\nReview documents for compliance with applicable internal policies and regulations(e.g study protocols, Periodic Safety Reports, etc.)\\\\n\\\\nIdentify regulatory risks and communicate mitigations to Regulatory lead and cross functional teams.\\\\n\\\\nUnderstand the regulatory framework, including regional trends, for various types of applications and procedures spanning a product’s lifecycle for small and large molecules globally.\\\\n\\\\nProvide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.\\\\n\\\\nContribute to process improvement to maintain and continuously improve regulatory consistency.\\\\n\\\\nOversee general Regulatory compliance in assigned markets/regions and escalate any compliance issues.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Skills
- Lc-Ms
- Uv-Vis Chem. Station
- Pc Chrom
- Gc Chem. Station
- Gas Chromatography
- Caenorhabditis Elegans Survival and Reproduction Assays
- Acquity Console
- Lims
- Atlas
- Linux
- Gc-Ms
- Trackwise
- Liquid Chromatography-Mass Spectrometry (Lc-Ms)
- Ftir
- Empower
- Tsspro 3.0
- Mass Hunter
- Icp-Ms
- Mass Lynx
- Gc
- Uv Probe 2.33
- Uv/Vis Spectroscopy
- Epsilonec-Usb
- Fluorometer
- Ion Chromatography
- Vinci
- Uv/Vis
- High-Performance Liquid Chromatography (Hplc)
- Ic
- Hplc
- Sas Programming
- Organic Synthesis
- Ir
- Winlab
- Neugenesis
- Topspin 2.1
- Statistics
- Characterization
- Materials Studio
- Nmr
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