- Regulatory Strategy: Design compliant development pathways and plan global market launches.
- Submissions: Prepare and submit explicit documentation, such as clinical trial applications and marketing authorizations, to agencies like the US FDA or EMA.
- 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:

- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund

Education:

- Master's (Required)

Experience:

- regulatory affairs: 2 years (Required)

Work Location: In person

📌 Regulatory Affairs Executive (India)
🏢 ASPIRIT VISION SOLUTION
📍 India