Looking for a job

Gururaja Bhat Kunjarugiri

@gururajabhatkunjarug

Regulatory Affairs Manager at Clinchoice GmbH who grew a global regulatory team to 15 professionals.

At Clinchoice GmbH, I directed global regulatory strategy and lifecycle management across EU and international markets. I also served as PRRC under EU MDR Article 15 and supported technical documentation, Notified Body interactions, and PMS activities.

I built and mentored a team of 15 regulatory professionals and introduced KPI-driven submission tracking that improved submission timeliness and dossier quality. Earlier, at Kinapse and AstraZeneca, I managed regulatory submissions and dossier publishing for global markets.

Experience

Work history, roles, and key accomplishments

Manager, Regulatory Affairs

Clinchoice GmbH

Aug 2015 - Apr 2026 (10 years 8 months)

Directed end-to-end global regulatory strategy and lifecycle management for EU and ROW markets across pharmaceutical and healthcare portfolios. Led a team of 15 regulatory professionals and implemented KPI-driven process improvements.

Regulatory Strategy EU MDR PRRC Technical Documentation Notified Bodies PMS PMCF Regulatory Intelligence Team Leadership Process Improvement KPIs Project Management

Specialist, Regulatory Operations

Kinapse

Oct 2012 - Aug 2015 (2 years 10 months)

Managed electronic and paper-based regulatory submissions for major pharmaceutical clients. Performed quality reviews of regulatory dossiers and supported document management and compliance activities.

Regulatory Submissions Quality Review Document Management Compliance

Dossier Manager

AstraZeneca

Mar 2011 - Oct 2012 (1 year 7 months)

Managed regulatory dossier publishing activities supporting global submissions including US and Canadian markets. Ensured compliance with submission formatting requirements and contributed to process improvements.

Regulatory Publishing Standards Submission Compliance Process Improvement