Senior Regulatory CMC Lead

Responsibilities

• Global Regulatory CMC Strategy
• Antibody-Drug Conjugate (ADC) CMC Expertise
• Biologics MAA/BLA Submission (Module 3)
• Regulatory Risk Assessment & Mitigation
• Health Authority Interaction (FDA / EMA)
• Regulatory Intelligence & ICH Compliance
• Cross-Functional Matrix Leadership
• Stakeholder Management & Communication
• Project Prioritization & Timeline Management
• Strategic Decision-Making in Regulatory Affairs

Skills

• eCTD / Regulatory Submission Platforms
• Regulatory Information Management (RIM) Systems
• Microsoft Office Suite
• Data Analysis Tools (Excel)

Qualifications

Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Biological Sciences, Regulatory Affairs. Preferred: PhD, PharmD, Master's in Regulatory Affairs, Master's in Pharmaceutical Sciences, MBA.

Requirements

• Biotechnology
• Pharmaceutical
• Biologics Development
• Antibody-Drug Conjugate (ADC) Programs
• Oncology Therapeutics
• Regulatory Affairs
• Global Health Authority Submissions