Assistant Manager, GRA Business Process
Core
Develop, optimize, and implement compliant business processes and documentation (SOPs, WIs, JAs, QRGs) for Global Regulatory Affairs to ensure consistent execution across global teams.
Role type
Assistant Manager, Regulatory Business Process
Builds
Standard Operating Procedures, Work Instructions, Job Aids, Quick Reference Guides, and process documentation for global regulatory compliance.
Domain
Healthcare / Pharmaceutical / Regulatory Affairs
Required skills
Regulatory Affairs experience, process documentation, workflow analysis, information design, electronic document routing, project management, Visio, SharePoint, Documentum
Preferred skills
Process design, flowcharting
Responsibilities
Develop high-quality SOPs, WIs, JAs, and QRGs; Draft new business processes based on SME input; Participate in process design meetings and workflow reviews; Incorporate visual elements to enhance usability; Partner with Compliance, L&D, and Metrics teams; Coordinate review and approval processes; Maintain documentation repositories and version control; Identify documentation gaps and improvement opportunities; Support regulatory process adherence oversight; Conduct periodic reviews of business processes.
Seniority
Manager, hands-on IC