RA Senior Manager OH Category
Core
Provide regulatory management, governance, and expertise to ensure successful global introduction and maintenance of products in the Oral Health category.
Role type
Senior Manager, Regulatory Affairs
Builds
Global regulatory strategies and compliant product portfolios for Oral Health brands
Domain
Consumer Healthcare / Oral Health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
scientific interpretation of technical information, strategic regulatory thinking, planning and organizing regulatory pathways, data analysis, report writing, cross-functional influence, change control management, claims development aligned to regulations
Preferred skills
mentoring team members, leading non-product related activities, pioneering new processes
Technologies
CMC sections, PIFs, MDTFs, TMACs briefing books, clinical trials applications/INDs, Variations
Responsibilities
Act as a business partner providing regulatory advice on drug/cosmetic/device/food/supplement development and lifecycle maintenance; Develop novel regulatory strategies to secure competitive approvals; Provide CMC evaluations for potential changes; Communicate regulatory technical requirements and facilitate submissions; Plan and deliver high-quality regulatory files to timelines; Support development of strong consumer claims within regulations; Ensure compliance with global, regional, and local processes and SOPs
Seniority
Senior Manager, hands-on IC with team management potential
