Regulatory Affairs Associate

About the Role

The Regulatory Affairs Associate is a full-time, on-site role based in Nagpur. This role is responsible for preparing, reviewing, and maintaining regulatory documentation in accordance with applicable laws and guidelines.

Key Responsibilities

• Supporting regulatory submissions.
• Tracking approvals.
• Ensuring that products and processes comply with current regulatory requirements.
• Coordinating with internal teams and external stakeholders to gather necessary information.
• Updating records.
• Responding to regulatory queries.
• Monitoring changes in regulations.
• Assisting in the implementation of compliance policies.
• Maintaining organized documentation and reporting systems.

Requirements & Tech Stack

• Regulatory Documentation
• Regulatory Submissions
• Regulatory Compliance
• Understanding of Regulatory Requirements
• Foundational knowledge in Regulatory Affairs
• Strong attention to detail
• Analytical thinking
• Ability to interpret regulatory guidelines
• Effective written and verbal communication skills
• Ability to work on-site in Nagpur
• Ability to manage multiple tasks
• Ability to meet deadlines in a structured environment

Qualifications

• Relevant academic background in pharmacy, life sciences, healthcare, or a related field is preferred.
• Previous experience or internships in regulatory affairs, quality assurance, or related healthcare compliance roles will be an advantage.