Strategy Lead, Submission Automation
Core
Shaping and advancing business strategy, roadmap, and cross-functional execution for report automation supporting regulatory dossier submissions (INDs, BLAs) across pharmaceutical modalities.
Role type
Strategy Lead, Submission Automation
Builds
Scalable business and systems strategies for submission-related reporting automation
Domain
Pharmaceutical R&D / Regulatory Affairs / Digital Strategy
Deliverable
product features
Required skills
Strategy formulation, Business process enablement, Program leadership, Cross-functional stakeholder management, Roadmap development, Regulatory environment knowledge
Preferred skills
Submission process expertise, Dossier management experience, Report automation knowledge, Technical partnership
Technologies
None explicitly stated
Responsibilities
Lead strategy and roadmap for report automation; Partner with dossier management and stakeholders to identify automation opportunities; Align business needs with technical delivery teams; Facilitate cross-functional decision-making and issue resolution.
Seniority
Senior, hands-on IC with team leadership potential