Industry: Pharmaceuticals
Experience Required: 3–5 Years
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.- 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.
- 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.
- 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
Salary
Hourly based
Location
PB , India PB, India
PB , India PB, India
