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Sai Vinusha

@saivinusha

Senior Regulatory Affairs professional driving global submissions, labeling, and lifecycle compliance for pharma and devices.

India

Message

What I'm looking for

I seek roles where I can lead global regulatory submissions, optimize labeling and lifecycle processes, mentor teams, and drive compliance improvements in collaborative, client-focused environments.

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.

Experience

Work history, roles, and key accomplishments

Current

Senior Consultant - Regulatory Affairs

Current

Kamet Consulting Group

Feb 2025 - Present (8 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.

Regulatory Intelligence SOP Development EU MDR Regulatory Submissions Process Optimization Mentoring

Regulatory Solutions Consultant

Clarivate

May 2022 - Apr 2024 (1 year 11 months)

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.

Project Management Budget Management Client Engagement Presentation Editorial

Regulatory Affairs Consultant

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.

Label Management ANDA Submissions PLM Systems Regulatory Strategy Labeling Ecosystem Assessment literature review

Executive Regulatory Affairs

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.

Dossier Labeling Regulatory Submissions Training

Researcher

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.

Competitive Analysis Regulatory Intelligence Reporting Data Management Analytical Skills

Education

Degrees, certifications, and relevant coursework

Krishna University

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.