Senior Manager Regulatory Affairs

Fraser Dove International is partnering exclusively with a pioneering biotechnology organisation operating in Italy, committed to advancing innovative therapies to address unmet medical needs. Our client is seeking a strategic leader to drive CMC regulatory activities and guide product development across the lifecycle.

• Develop and execute robust CMC regulatory strategies that support clinical development and commercial readiness
• Ensure timely, high‑quality regulatory submissions and approvals across global markets
• Strengthen cross‑functional collaboration and regulatory compliance to support innovation and product lifecycle management

• Lead CMC regulatory strategy for clinical and commercial stage products, including preparation of dossier sections and risk assessments
• Collaborate with regulatory authorities such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA) to define development pathways
• Manage regulatory submissions including Investigational New Drug (IND), Biologics License Application (BLA), Marketing Authorisation Application (MAA), and variations
• Support inspections and regulatory interactions, ensuring compliance of CMC documentation
• Oversee supplier and Contract Development and Manufacturing Organisation (CDMO) regulatory activities and ensure compliance with Good Manufacturing Practice (GMP)
• Contribute to innovation in development platforms, particularly in gene therapy and advanced therapies
• Monitor regulatory changes and assess impact on development and submission strategies

• 8 to 10 years of experience in CMC regulatory affairs within the biopharmaceutical industry
• Proven experience delivering regulatory strategies and submissions across clinical and commercial stages
• Experience engaging with regulatory authorities such as EMA and FDA
• Strong leadership and stakeholder management capabilities
• Deep understanding of GMP, quality systems, and regulatory compliance
• Bachelor of Science (BSc) in a relevant scientific discipline
• Doctor of Philosophy (PhD) or equivalent postgraduate qualification is desirable

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related.