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@saivinusha
Senior Regulatory Affairs professional driving global submissions, labeling, and lifecycle compliance for pharma and devices.
I am a Senior Regulatory Affairs professional with nine years' experience delivering global submission support, labeling change management, and lifecycle compliance for pharmaceutical and medical device clients. I have led rebranding labeling projects, prepared ANDAs and post-approval submissions, and implemented regulatory intelligence systems that improved compliance across multiple regions.
I consistently optimize submission workflows, refine SOPs and SPL processes, and mentor junior consultants to raise team capability. My work has improved budget performance, increased client satisfaction, and strengthened regulatory readiness through data-driven assessments and process improvements.
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Work history, roles, and key accomplishments
Kamet Consulting Group
Feb 2025 - Present (9 months)
Designed and upgraded regulatory intelligence systems and managed labeling changes for medical device rebranding, improving compliance and submission governance across global markets. Refined SPL workflows and SOPs to strengthen submission lifecycle controls and mentored junior consultants.
Managed regulatory projects to budget and schedule, achieving a 20% improvement in budget target performance and increasing client satisfaction by 15% through delivery of consulting solutions and on-time project execution. Led proposals, presentations, and editorial content for regulatory communications.
Freelancer
Jun 2020 - May 2022 (1 year 11 months)
Delivered labeling change management, ANDA preparation and post-approval USFDA submissions, and conducted labeling ecosystem maturity assessments to harmonize processes and technologies across client organizations. Managed project milestones to ensure on-time regulatory delivery.
Celon Laboratories Pvt. Ltd
Jan 2017 - Apr 2020 (3 years 3 months)
Coordinated preparation and submission of regulatory dossiers to semi-regulated and ROW markets, improving documentation accuracy by 20% and reducing re-submissions through precise labeling and PIL creation. Responded to regulatory queries and trained new associates.
Eli India Research Pvt Ltd
Sep 2015 - Dec 2016 (1 year 3 months)
Conducted competitive data analysis of product portfolios, trials, and regulatory statuses and maintained database records to accelerate project timelines and improve research quality for pharmaceutical clients.
Degrees, certifications, and relevant coursework
Master of Pharmacy, Pharmaceutics
2012 - 2014
Completed a Master of Pharmacy (Pharmaceutics) program with coursework and research focused on pharmaceutics and drug formulation between 2012 and 2014.
Bachelor of Pharmacy, Pharmacy
2008 - 2012
Completed a Bachelor of Pharmacy program covering pharmaceutical sciences and foundational pharmacy topics from 2008 to 2012.
Software and tools used professionally
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