Head of Global Regulatory Affairs CMC

Experteer Overview

As Regulatory CMC Lead at Alfasigma, you define and execute global regulatory strategies for CMC across product life cycles. You will influence development, registration, and lifecycle management, collaborating across functions to align with product strategies. You will bundle scientific rigor with regulatory insight to enable submissions and lifecycle changes, while advancing digital and data-driven CMC processes. You’ll work with global health authorities and help shape a ONE Team approach focused on patients.

Retribuzione / Benefits

• Define and lead global CMC strategies for development, registration, and post-approval lifecycle management
• Develop high-quality CMC regulatory dossiers including Module 3, justifications, and specifications
• Align CMC regulatory approaches with overall development and commercialization plans
• Provide regulatory input on critical milestones (IND/CTA, BLA/NDA, MAA)
• Lead regulatory support for manufacturing changes, site transfers, scale-ups, and tech transfers
• Represent CMC in interactions with global health authorities (FDA, EMA)
• Establish and manage global CMC change management frameworks to minimize regulatory risk
• Drive continuous improvement, standardization, and efficiency in CMC processes
• Champion digital transformation and data standards in CMC regulatory activities
• Promote a cross-functional, ONE Team culture and build a fit-for-future team
• Ensure data integrity and effective use of regulatory information management systems (RIM)
• Oversee alignment of CMC activities across markets to ensure consistency

Responsabilità

• 15+ years of experience in regulatory affairs with a strong CMC focus
• Deep expertise in FDA, EMA, and ICH guidelines
• Proven leadership of global teams and complex regulatory programs
• Track record of successful major filings and global product approvals
• Advanced degree in chemistry, pharmacy, chemical engineering, or related science (PhD preferred)

Requisiti fondamentali

• competitive salary
• comprehensive benefits
• extensive opportunities for professional growth and development