Drug Regulatory Compliance Officer

Job Title: Assistant Manager – Drug Regulatory Compliance
Industry: Pharmaceuticals
Experience Required: 3–5 Years

Job Summary:

We are seeking a detail-oriented and proactive Assistant Manager – Drug Regulatory Compliance to ensure compliance with regulatory standards applicable to pharmaceutical products. The role involves managing end-to-end regulatory submissions, monitoring compliance with REACH, FSSAI, CDSCO, and other relevant national and international guidelines.

Key Responsibilities:

• Ensure compliance with drug regulations, REACH compliance, FSSAI guidelines, and applicable international standards.
• Prepare, review, and submit regulatory documents, dossiers, and product registrations.
• Liaise with regulatory authorities (CDSCO, FSSAI, etc.) for approvals, renewals, and queries.
• Monitor changes in global and domestic regulatory requirements and update internal processes accordingly.
• Coordinate with cross-functional teams (R&D, Quality, Manufacturing, Supply Chain) to ensure timely submissions and product compliance.
• Maintain regulatory documentation and records as per SOPs and audit requirements.
• Support audits and inspections by internal/external regulatory authorities.
• Provide training and guidance to teams on regulatory compliance updates and best practices.

Desired Candidate Profile:

• Bachelor’s/Master’s in Pharmacy, Life Sciences, Chemistry, or related field.
• 3–5 years of regulatory compliance experience in the pharmaceutical/healthcare/food industry.
• Good knowledge of Drug Regulatory Affairs, REACH, FSSAI, CDSCO regulations.
• Strong understanding of regulatory documentation and submission processes.
• Excellent communication and liaison skills for interacting with authorities and internal stakeholders.
• Detail-oriented with strong organizational and analytical skills.

Key Skills:

• Regulatory Affairs & Compliance
• REACH Compliance
• FSSAI Guidelines
• CDSCO Regulations
• Documentation & Dossier Preparation
• Audits & Inspections Handling

Job Type: Full-time

Pay: ₹400,000.00 - ₹600,000.00 per year

Work Location: In person