Position: Regulatory Affairs Associate

Department: Scientific and Regulatory Affairs

Location: Bengaluru, Karnataka (On- Site)

Reporting To: Manager, Scientific and Regulatory Affairs

Role Overview:

Regulatory Affairs Associate with experience to develop, review, and manage high-quality regulatory documentation in compliance with applicable guidelines and standards.

Key Responsibilities:

· Prepare, review, and coordinate regulatory submissions, including applications for approvals, amendments, and clarifications.

· Track and follow up on submission status and ensure timely responses to queries raised by regulatory agencies.

· Prepare and submit regulatory amendments, notifications, responses to deficiency letters, and supporting documentation within prescribed timelines.

· Review regulatory dossiers and supporting documents for accuracy, consistency, and compliance with current regulatory requirements.

· Facilitate and coordinate meetings, presentations, and discussions with regulatory officials to support ongoing and upcoming projects.





· Maintain updated knowledge of Indian regulatory frameworks, including CDSCO MDR 2017, NDCT rules 2019, Drugs and Cosmetics Act and Rules, ICMR guidelines, and other applicable standards.

· Draft and review regulatory correspondence, meeting notes, and briefing documents.

· Contribute to SOP development, revision, and implementation.

· Develop, maintain, and update related templates, forms, checklists, logs, and standard document formats.

· Ensure controlled documents are current, approved, and available to project teams.

· Support implementation and continuous improvement of documentation processes.

· Maintain document repositories.

· Assist in audit and inspection readiness activities.

· Maintain meeting minutes, project trackers for all regulatory deliverables.

· Track document progress, review status, comments reconciliation, and approval workflows.

· Track key milestones, deliverables, and project timeline

📌 Regulatory Affairs Associate (Bengaluru)
🏢 TrialGuna
📍 Bengaluru