Manager of GRAAS Operations - Remote

Overview

The Manager of GRAAS Operations is responsible for overseeing regulatory submissions in the pharmaceutical or biotechnology industry, ensuring compliance and timely delivery through effective project management and collaboration with cross-functional teams.

In Short

• Remote position with a preference for candidates in the West Coast time zone.
• Requires at least four years of experience in regulatory operations.
• Expertise in eCTD publishing and submission assembly is essential.
• Strong planning and timeline negotiation skills are necessary.
• Detail-oriented with the ability to quality-check submissions.
• Experience with Docu Bridge or similar tools is a plus.
• Manage Clinical Trial and Marketing Application submissions.
• Provide guidance on dossier deployment strategies.
• Lead process development and improvement initiatives.
• Technical support for regulatory systems is required.

Requirements

• Doctorate degree or equivalent experience.
• Master’s degree with 3 years of experience.
• Bachelor’s degree with 5 years of experience.
• Associate’s degree with 10 years of experience.
• High school diploma/GED with 12 years of experience.

Benefits

• Flexible work environment.
• Opportunity to work on impactful regulatory projects.
• Collaboration with cross-functional teams.
• Professional development opportunities.
• Competitive pay based on experience.