Global Regulatory Manager, GRSS&C
Core
Managing regulatory clinical trial applications and maintenance submissions for a product portfolio across selected countries/regions to ensure timely approvals and compliance.
Role type
Senior individual contributor regulatory manager
Builds
Regulatory submissions and approvals for clinical trials and maintenance activities
Domain
Pharmaceutical industry, regulatory affairs
Required skills
Regulatory submission and approval processes, Clinical trial applications, Maintenance activities, Regulatory compliance, Country/region knowledge, HA query management, Compliance database management, Process improvement, Safety and efficacy data understanding
Preferred skills
Advanced degree (MD, Ph D, PharmD), Global/matrix environment experience, Cross-functional team experience
Technologies
Compliance database, RIMs
Responsibilities
Prepare clinical trial applications and maintenance submissions on time and in compliance, Manage assigned product portfolio and country/region knowledge, Identify issues and gaps to avoid delays, Manage responses to HA queries, Enter product specific attributes in compliance database, Facilitate preparation of documents for HA interactions, Contribute to productivity and automation initiatives
Seniority
Senior, hands-on IC