Executive - Regulatory Affairs

Svizera Health Remedies; Mumbai; On-site; INR 600,000 - 800,000; Full time

Job summary

Svizera Health Remedies is looking for a detail-oriented Executive Regulatory Affairs to ensure compliance with regulatory requirements related to product registration and approvals. The candidate will prepare and submit regulatory dossiers while maintaining product licenses and liaising with authorities.

This role demands strong knowledge of regulatory guidelines and documentation practices, preferably in the pharma, medical device, or FMCG sectors.

Qualifications

• Strong knowledge of regulatory guidelines applicable to pharma/medical device/FMCG industries.
• Detail-oriented and proactive approach to regulatory compliance.
• Experience in preparing and submitting regulatory dossiers.

Responsibilities

• Prepare, compile, and review regulatory documents and dossiers for submission.
• Ensure timely submission, approval, and renewal of product registrations.
• Maintain regulatory databases and documentation for assigned products.
• Review and approve product labeling and promotional materials for compliance.

Skills

Regulatory guidelines

Documentation practices

Submission processes

Good Regulatory Practices (GRP)

Job description

Job Summary

We are seeking a detail-oriented and proactive Executive Regulatory Affairs to ensure compliance with all regulatory requirements related to product registration, documentation, and approvals. The role involves preparing and submitting regulatory dossiers, maintaining product licenses, and liaising with authorities to support timely market access and product lifecycle management.

The ideal candidate will have strong knowledge of regulatory guidelines, documentation practices, and submission processes applicable to [pharma / medical device / FMCG] industries.

Key Responsibilities

• Prepare, compile, and review regulatory documents and dossiers for submission to national and international health authorities.
• Ensure timely submission, approval, and renewal of product registrations, licenses, and certificates.
• Maintain regulatory databases, tracking systems, and documentation for all assigned products.
• Support new product launches, variations, and post-approval changes by coordinating with cross-functional teams (QA, QC, R&D, Production).
• Review and approve product labeling, artwork, and promotional materials for regulatory compliance.
• Keep abreast of latest regulatory requirements, notifications, and updates from relevant authorities (CDSCO, FDA, EMA, WHO, etc.).
• Coordinate with regulatory agencies, consultants, and partners for submissions and clarifications.
• Participate in audits and inspections, providing required documentation and responses.
• Ensure compliance with Good Regulatory Practices (GRP) and company SOPs.
• Support regulatory intelligence activities and contribute to process improvements.