Regulatory Strategy: Design compliant development pathways and plan global market launches.
Submissions: Prepare and submit transparent 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 Valuable 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

Perks
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 Roorkee
🏢 ASPIRIT VISION SOLUTION
📍 Roorkee