Associate 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, compliant approvals.
Role type
Associate Global Regulatory Manager (Clinical Trials & Maintenance)
Builds
Regulatory submissions for clinical trial applications and portfolio maintenance
Domain
Pharmaceutical industry, Regulatory Affairs
Required skills
Regulatory submission processes, Clinical trial regulations, Country/region regulatory knowledge, Compliance database management, HA query response, Product label understanding, Process improvement, Cross-functional collaboration
Preferred skills
Advanced degree (MD, PhD, PharmD), Data Analysis, Waterfall Model
Technologies
Compliance database, RIMs
Responsibilities
Prepare clinical trial applications and maintenance submissions ensuring compliance with regulations and company processes; Manage assigned product portfolio and country/region knowledge; Identify issues and gaps to minimize submission delays; Respond to Health Authority (HA) queries and prepare justifications; Enter product attributes in compliance databases; Facilitate document preparation for low-complexity HA interactions; Contribute to productivity and automation initiatives; Share knowledge within Regulatory Affairs.