Regulatory Affairs Assistant

1 day ago


hyderabad, India Gamut HR Solutions Full time

Company OverviewGamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at Job OverviewWe are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.Qualifications and SkillsProficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.Familiarity with GxP standards to assure the quality and integrity of processes and products.Experience in quality management systems to oversee processes meeting both internal and external requirements.Understanding of labeling requirements to ensure product labels meet regulatory standards.Roles and ResponsibilitiesAssist in the preparation and submission of regulatory documents to appropriate regulatory bodies.Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.Monitor and track submissions and ensure all regulatory timelines are met.Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.Provide support in the development of regulatory strategies and implementation plans.Liaise with internal departments to ensure regulatory compliance is maintained across all projects.Prepare and review technical documentation to ensure compliance with regulatory standards.Support internal and external audits by gathering necessary documents and evidence.



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