Head of Global Regulatory Affairs CMC

Overview

This position is responsible for defining and executing global regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) across the product lifecycle. This role ensures robust regulatory CMC strategies, submission generation, compliance, and alignment with global health authority expectations for pharmaceutical and biologics products. It plays a critical role in enabling product development, approvals, and lifecycle management through strong scientific, regulatory, and operational leadership.

Your Role

• Define and lead global regulatory CMC strategies and execution for development, registration, and post-approval lifecycle management, leveraging frameworks such as RELIANCE where appropriate.

• Ensure alignment of CMC regulatory approaches with overall product development and commercialization strategies, partnering cross-functionally to ensure aligned approach.

• Provide strategic input into critical development milestones (e.g., IND/CTA, BLA/NDA, MAA).

• Oversee the development of high-quality CMC regulatory dossiers, including Module 3 content and supporting documentation, including rigor in CMC regulatory justifications, control strategies, comparability, and specifications.

• Ensure alignment with ICH guidelines and evolving regulatory science expectations, proactively communicating these and their impact for Alfasigma across the organization.

• Lead regulatory support for manufacturing changes, site transfers, scale-ups, and technology transfers.

• Serve as the senior regulatory CMC representative in interactions with global health authorities (e.g., FDA, EMA).

• Establish global frameworks for CMC change management, ensuring compliance and minimizing regulatory risk.

• Drive efficient handling of complex changes (e.g., process improvements, new technologies, dual sourcing).

• Ensure global alignment and consistency across markets.

• Drive continuous improvement, standardization, and efficiency across regulatory CMC processes.

• Champion digital transformation in CMC regulatory (e.g., structured content, submission systems, data standards).

• Ensure data integrity and effective use of regulatory information management systems (RIM).

• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority.

• Build a strong team and continuously grow the individual team members to create and maintain Fit-for-Future capabilities.

The role is preferably based at one of our Italian locations: Bologna, Milan, or Pomezia.

Profile description

Who are you:

• 15+ years of experience in regulatory affairs with strong focus on CMC
• Deep expertise in global CMC regulatory requirements (FDA, EMA, ICH guidelines)
• Proven leadership of global teams and complex regulatory programs
• Demonstrated success in major filings and global product approvals
• Advanced degree in chemistry, pharmacy, chemical engineering, or related scientific discipline (PhD preferred)
• Strategic regulatory leadership and decision-making
• Deep CMC scientific and technical expertise
• Strong understanding of pharmaceutical manufacturing processes
• Health authority interactions and relationship management
• Proven ability to be hands-on, agile and lead organizational efforts and innovation by example
• Strong verbal, written, and technical communication skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Company grows
• Ability to work effectively across a highly complex, fast paced, matrix organization
• Understanding of the legal and compliance environment
• Influential and motivating
• Digital mindset and data-driven leadership
• Advanced functional experience with MS Office Suite

Competencies & Major Skills

• Strategic regulatory leadership and decision-making
• Deep CMC scientific and technical expertise
• Strong understanding of pharmaceutical manufacturing processes
• Health authority interactions and relationship management
• Proven ability to be hands-on, agile and lead organizational efforts and innovation by example
• Strong verbal, written, and technical communication skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Company grows
• Ability to work effectively across a highly complex, fast paced, matrix organization
• Understanding of the legal and compliance environment
• Influential and motivating
• Digital mindset and data-driven leadership
• Advanced functional experience with MS Office Suite

We offer

Why Join Alfasigma: At Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.