GRA Labelling Group Lead
Core
Lead a team of labeling strategists to create, update, and approve regulatory labeling documents (CCDS, US, EU, WHO) and patient leaflets for pharmaceutical products throughout the development and marketing lifecycle.
Role type
Senior Group Lead, Regulatory Affairs (Labeling)
Builds
Regulatory labeling dossiers, patient leaflets, and submission materials for new Marketing Authorizations and updates to existing products.
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory labeling strategy, team leadership, resource planning, cross-functional negotiation, KPI monitoring, project portfolio management, stakeholder management, risk identification, training and mentoring.
Preferred skills
Experience with drug-device combinations, matrix team management, process improvement.
Technologies
CCDS, FDA, EMA, WHO guidelines, portfolio management tools.
Responsibilities
Recruit, hire, and onboard labeling team members; define role competencies and execute training plans; manage performance, goal setting, and coaching; assign and balance product responsibility across the team; forecast capacity and manage resource planning for 250+ products; lead multi-disciplinary working groups to build consensus on labeling proposals; coordinate end-to-end labeling review and approval for regulatory submissions; provide strategic guidance on complex labeling projects; chair Labeling Review Committee presentations; interpret health authority requirements (FDA, EMA); lead competitive/comparator analysis for labeling.
Seniority
Senior, hands-on IC with people management