Head of Regulatory CMC JB-32

The Head of regulatory CMC is responsible for the overall regulatory-related CMC activities throughout the product life-cycle management, including: early development stages, phase 1-3 clinical development, BLA and Post Marketing requirements and activities.

The Head of CMC will work collaboratively with cross-functional teams, including R&D, analytical, QC/QA, clinical and supply chain as well as liaise with CMOs, regulatory consultants and company’s global partners.

The Head of regulatory CMC will report to the Head of Regulatory Affairs. The position requires presence at the Carmiel office at least 3 times a week

Key Responsibilities

• Ensure phase-appropriate CMC regulatory compliance
• Lead the preparation and writing of CMC sections in FDA/EMA/ROW regulatory submissions
• Writing of CMC-related regulatory documents
• Oversee the activities with cross-functional teams to compile and submit high-quality dossiers within required timelines
• Oversee the CMC-related responses to Health Authorities
• Serve as the regulatory CMC- subject matter expert in cross-functional project meetings as well as in meetings with Health Authorities
• Maintain up-to-date knowledge of FDA/EU/ICH CMC-related guidance
• Responsible to lead and guide CMC staff, including the development of a CMC-related training program
• Liaising with CMC regulatory consultants
• Support Regulatory submission and activities as needed

Qualifications

• Education: Master's or PhD in a relevant scientific discipline,
• Experience: 10+ years of experience in CMC regulatory affairs of innovative drugs within the pharmaceutical industry, including FDA/EMA submissions
• Knowledge: Understanding of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines
• Experience with regulatory submissions for biologics (Must) and Drugs
• Previous experience with leading regulatory CMC projects

Skills and Competencies

• Excellent written and verbal communication skills in English and Hebrew
• Strong project management and organizational skills
• Ability to manage multiple projects simultaneously and meet tight deadlines
• Leadership and matrix management capabilities