Regulatory Strategy: Design compliant development pathways and plan global market launches.
- Agency Communication: Act as the primary contact for health authorities, answering questions and managing negotiations during reviews.
- Compliance Oversight: Ensure all research, manufacturing, and laboratory processes follow standards like Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
- Labeling and Artwork: Create and update package leaflets, prescribing information, and promotional materials to match approved legal standards.
- Lifecycle Management: Handle post-approval changes, safety updates, renewals, and manufacturing variations.
- Regulatory Intelligence: Track changing laws and global legislation to assess their impact on company portfolios.
Pay: ₹25,000.00 - ₹60,000.00 per month
Benefits:
- Versatile schedule
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
Education:
- Master's (required)
Experience:
- regulatory affairs: 2 years (required)