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 highly complex submissions across global regions.
Role type
Senior IC Regulatory Affairs Manager (International)
Builds
Global regulatory submissions for new medicines and product extensions
Domain
Biopharmaceuticals / International Regulatory Affairs
Required skills
Regulatory submission strategy, cross-functional leadership, risk identification and mitigation, stakeholder management, project management, regulatory framework knowledge, process improvement
Preferred skills
Regulatory Information Management system (RIM) experience, multi-disciplinary team leadership, experience working with international regions outside India
Technologies
MS Project, document management tools
Responsibilities
Develop and execute submission delivery plans and content plans; coordinate input and revision of project plans; identify regulatory risks and propose mitigations; liaise with cross-functional teams and health authorities; provide coaching and mentoring on international markets; contribute to process improvement.
Seniority
Senior, hands-on IC