MT-Regulatory Affairs

Genpact is seeking a Lead Associate - Regulatory Affairs to support a client's regulatory submissions for small molecules, biologics, and combination products. The successful candidate will be responsible for providing scientific inputs, monitoring assumptions, and managing regulatory post-approval Chemistry, Manufacturing and Controls (CMC) changes.

Requirements

• Bachelor's degree in Pharmaceutical Science, Engineering, or related field
• Minimum 2-3 years of experience in CMC tasks and related aspects
• English language proficiency
• Good understanding of regulatory requirements and guidelines

Benefits

• Competitive salary
• Opportunities for career growth and development
• Diverse and inclusive work environment
• Equal Opportunity Employer