Manager, Regulatory Operations and Publishing

📋 Description

• The Manager, Regulatory Operations and Publishing oversees regulatory submission operations
• Coordinate stakeholders to deliver accurate regulatory submissions in a fast-paced life sciences
• Prepare, format, and publish complex regulatory documents per internal standards and regulatory
• Generate submission-ready PDFs while complying with eCTD requirements and technical specifications.
• Perform detailed technical quality control reviews of regulatory documents and published submission
• Oversee submission execution activities, track deliverables, manage timelines, and assess

🎯 Requirements

• Bachelor’s degree with at least 4 years experience in Regulatory Operations or related function.
• Expertise in regulatory document preparation, formatting, PDF publishing, and submission management.
• Strong understanding of eCTD submission structures, PDF specs, bookmarks, hyperlinks, file naming
• Experience performing technical quality control reviews of regulatory submissions.
• Familiarity with regulatory information management systems (Veeva Vault RIM preferred).
• Experience with Accenture StartingPoint Templates preferred.

🎁 Benefits

• Competitive annual salary range of approximately $134,505 - $162,988 USD, depending on skills
• Potential eligibility for additional incentive compensation opportunities.
• Remote work flexibility within the United States.
• Comprehensive health coverage, including medical, pharmacy, dental, and vision plans.
• Wellness programs and employee assistance resources.
• Retirement benefits, including a 401(k) plan.