Regulatory Affairs Manager

Responsibilities

• Prepare and submit regulatory dossiers to DCGI and global boards.
• Manage correspondence through approval.
• Advise on regulatory strategy and gap analysis.
• Maintain compliance with evolving CDSCO and FDA guidance.

Requirements

• Degree in Pharmacy, Life Sciences or related field.
• 6+ years in regulatory affairs within a CRO or pharma.
• Hands-on DCGI and FDA submission experience.
• Excellent scientific writing skills.