About this role

drive global regulatory strategies for pharmaceutical and vaccine products
guide products from early development to market by creating smart regulatory strategies
prepare high-quality regulatory submissions, manage compliance, and anticipate regulatory trends
conduct risk assessments and serve as the primary liaison with regulatory authorities including FDA and EMA
collaborate across R&D, Manufacturing, and Quality teams in strategic negotiations with health authorities worldwide

6+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
experience responding to Health Authority questions
experience preparing regulatory documentation and familiarity with standard submission processes
understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
strong written and verbal communication skills, with fluency in English
capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site)

Global Regulatory Affairs Lead – Chemistry, Manufacturing and Controls

Key skills