International API Registration & Project Manager (m/w/d)
Core
Lead scientific and project management for the international API registration of the active ingredient Ectoin, focusing on markets in the USA, China, and India.
Role type
Senior regulatory project manager (pharmaceuticals)
Builds
Regulatory dossiers (DMF, CTD) and registration strategies for pharmaceutical active ingredients
Domain
Pharmaceuticals / Regulatory Affairs / Chemistry
Required skills
Pharmaceutical science background, regulatory strategy development, dossier coordination, project management, risk identification, stakeholder coordination
Preferred skills
API registration experience, Drug Master Files (DMF), CMC/CTD Module 3 knowledge, ICH guidelines familiarity, experience with US/China/India regulatory authorities
Technologies
DMF, CTD, ICH Guidelines
Responsibilities
Plan and coordinate international registration projects; develop and implement registration strategies; analyze country-specific regulatory requirements; coordinate scientific and technical documentation; manage project plans, milestones, and budgets; report to senior management on project status and risks.
Seniority
Senior, hands-on IC