Head of global regulatory affairs cmc

Scope of the role This position is responsible for defining and executing global regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) across the product lifecycle. It ensures robust regulatory CMC strategies, submission generation, compliance, and alignment with global health authority expectations for pharmaceutical and biologics products, enabling product development, approvals, and lifecycle management through scientific, regulatory, and operational leadership. Your Role Define and lead global regulatory CMC strategies and execution for development, registration, and post‑approval lifecycle management. Ensure alignment of CMC regulatory approaches with overall product development and commercialization strategies. 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. Ensure alignment with ICH guidelines and evolving regulatory science expectations, proactively communicating these and their impact for the company. 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). Promote a unified team approach, focusing on patient priority. Build and maintain a strong, fit‑for‑future team. Who are you: 15+ years of regulatory experience with a 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 discipline (Ph D preferred). Strategic regulatory leadership and decision‑making. Strong understanding of pharmaceutical manufacturing processes. Health authority interaction and relationship management. Hands‑on, agile, and innovative organizational leadership. Excellent verbal, written, and technical communication skills. Learning agility and scalability to grow with the company. Effectiveness across a highly complex, fast‑paced, matrix organization. Understanding of legal and compliance environment. Influential, motivating, and collaborative. Digital mindset and data‑driven leadership. Proficiency with MS Office Suite. Location: The role is preferably based at one of our Italian locations: Bologna, Milan, or Pomezia. Benefits We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. #J-18808-Ljbffr