Accelerate progress at the forefront of regulatory affairs, leading CMC strategy and submissions for development and post-approval programs across the EMEA region. Collaborate cross-functionally to ensure compliance and achieve regulatory approvals.
Champion regulatory excellence by leading CMC strategies for global drug approvals. Collaborate across teams to navigate complex regulations, ensuring compliance and successful product lifecycle management in a dynamic environment.
Lead CMC Pharmaceutical Development for small molecules, driving innovation and strategy from early development to commercialization while ensuring regulatory compliance and operational excellence.
Lead the charge in medical review for US and Global materials, ensuring scientific accuracy and compliance. Collaborate with cross-functional teams to deliver high-quality content that meets regulatory standards and supports business objectives.
Contribute to the safety and risk assessment of products throughout their lifecycle, providing medical expertise, conducting reviews, and ensuring compliance with pharmacovigilance regulations. Collaborate with teams for impactful safety monitoring.