Regulatory Submissions Program Lead

Altria; Richmond (VA); Hybrid; USD 105.000 - 152.000; Vollzeit

Benefits dieser Stelle

Relocation benefits

Hybrid work schedule

Paid time off and holidays

Zusammenfassung

Altria is seeking an Associate Manager, Regulatory Submissions in Richmond, VA, with a hybrid work schedule. You will coordinate cross-functional teams, maintain project plans, and help implement a Regulatory Information Management system to keep submissions compliant and on time.

The role requires 4+ years of relevant experience in project management, regulatory affairs, or related fields, and a Bachelor’s degree is preferred. Relocation benefits are provided in this position.

Qualifikationen

• Bachelor’s degree preferred in science, engineering, operations, business, project management, information systems, or related discipline.
• 4+ years of relevant experience in project management, regulatory affairs, science, operations, quality systems, IT-related fields, or cross-functional execution support.
• Experience using or implementing Regulatory Information Management (RIM) systems.
• Understanding of project management processes, preferably supporting FDA regulatory submissions.
• Experience supporting or maintaining project plans, dashboards, risk-management tools, and training materials.

Aufgaben

• Coordinate cross-functional teams to deliver regulatory submissions by maintaining project plans and timelines.
• Organize and compile information for regulatory submissions and FDA inquiries.
• Maintain and improve submission-management tools, trackers, dashboards, and risk logs.
• Help implement Regulatory Information Management (RIM) system with IT and external partners.
• Develop and maintain SOP/QMS documentation, templates, and training materials.
• Manage submission review and quality control to ensure accuracy and regulatory compliance.

Kenntnisse

Project management

Regulatory submissions

Cross-functional coordination

RIM systems

SOP/QMS documentation

Microsoft Office

Adobe Acrobat Pro

Ausbildung

Bachelor’s degree preferred in science or related discipline

Tools

RIM systems

Microsoft Office

Adobe Acrobat Pro

Jobbeschreibung

Altria is seeking an Associate Manager, Regulatory Submissions in Richmond, VA, with a hybrid work schedule. You will coordinate cross-functional teams, maintain project plans, and help implement a Regulatory Information Management system to keep submissions compliant and on time.

The role requires 4+ years of relevant experience in project management, regulatory affairs, or related fields, and a Bachelor’s degree is preferred. Relocation benefits are provided in this position.