15h Left! Regulatory Affairs Specialist-API

Role Summary / Key Responsibilities

• DMF compilation and submission to global markets
• Handling post approval submission and CIP assessments
• Submission of DMF amendment & response to Health Authority queries
• Providing customer support
• Evaluating change control assessment
• Providing Regulatory input for New molecule development activities
• Maintaining Regulatory data base

Qualification : M.Sc. / M. Pharm

Exp : 10 years - 16 years