Regulatory Affairs Assistant

2 weeks ago

Hyderabad, India Gamut HR Solutions Full time

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 .


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.

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