International Regulatory Affairs Manager
Core
Lead end-to-end planning, coordination, and execution of International Marketing Authorisation Applications (MAAs) and Clinical Line Extensions (CLEs) for drug development.
Role type
Senior IC Regulatory Affairs Manager
Builds
International market submissions for new medicines
Domain
Biopharmaceuticals / Global Regulatory Affairs
Required skills
Regulatory submission strategy, cross-functional team leadership, risk identification and mitigation, project management, regulatory framework knowledge, stakeholder management, process improvement
Preferred skills
Experience with Regulatory Information Management systems (RIM), experience managing deliverables at the project level, experience working with international teams outside India
Technologies
MS Project, document management tools
Responsibilities
Develop and execute submission delivery plans, coordinate input and revision of project plans, liaise with cross-functional teams, provide coaching and mentoring on international markets, contribute to process improvement
Seniority
Senior, hands-on IC