Company Overview

Gamut 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 http://gamuthrsolutions.com/.

Job Overview

We 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 Skills

• Proficiency 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 Responsibilities

• Assist 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.