Regulatory Affairs Officer

Job Role - Regulatory Affairs Officer

Experience - 3-8 years

Location - New Delhi

Key Responsibilities:

• Prepare, review, and submit regulatory documents for approvals, renewals, and registrations.
• Ensure compliance with local, national, and international regulatory requirements.
• Maintain up-to-date knowledge of changing regulations and advise internal teams on necessary actions.
• Liaise with regulatory authorities and ensure timely responses to inquiries or audits.
• Develop and implement regulatory strategies to support business objectives.
• Monitor post-market surveillance activities and ensure adherence to reporting requirements.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing.
• Assist in the development and review of labeling, packaging, and promotional materials to ensure compliance.
• Maintain regulatory databases and documentation to support audits and inspections.
• Provide training and guidance on regulatory requirements to internal teams.