International API Registration & Project Manager (m/w/d)
Core
Lead scientific and project-based responsibility for the international registration of the active ingredient Ectoin, focusing on the USA, China, and India.
Role type
Senior Regulatory Project Manager (API Registration)
Builds
Regulatory dossiers (including Drug Master Files) and registration strategies for pharmaceutical active ingredients.
Domain
Pharmaceutical industry / Regulatory Affairs / Active Ingredients
Deliverable
client delivery
Required skills
Project management, regulatory strategy development, scientific evaluation of manufacturing processes, dossier coordination, risk management, cross-functional collaboration, English (fluent)
Preferred skills
International API registration experience, Drug Master Files (DMF) knowledge, CMC and CTD Module 3 expertise, familiarity with ICH guidelines (Q7, Q11), experience with US/China/India regulatory authorities
Technologies
Drug Master Files (DMF), CMC, CTD Module 3, ICH Guidelines (Q7, Q11)
Responsibilities
Plan and coordinate international registration projects; develop and implement registration strategies; analyze country-specific regulatory requirements; coordinate the creation and submission of regulatory dossiers; evaluate scientific data and manufacturing processes; manage project plans, milestones, and budgets; report to senior management on project status and risks.
Seniority
Senior, hands-on IC