Specialist - Regulatory Planning & Publishing
Core
Plan, execute, and manage regulatory submissions for healthcare/consumer care products, ensuring quality and compliance while driving process improvements.
Role type
Specialist, Regulatory Planning & Publishing
Builds
Regulatory submissions (eCTD) and internal process improvements
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Affairs, Pharmacovigilance, Project Management, eCTD, Process Improvement, Risk Assessment, Submission Planning, Cross-functional Collaboration, MS Office (Advanced Excel/Word), Detail-Oriented
Preferred skills
Leadership, Mentoring, Coaching, Strategic Thinking, Innovation
Technologies
MS Office, Advanced Excel, Microsoft Word, eCTD
Responsibilities
Participate in submission planning forums to identify and communicate risks; Create and maintain submission plans in planning tools; Liaise with RPP organization areas to ensure timely submissions; Identify business process improvement opportunities and documentation updates.
Seniority
Mid-level, hands-on IC