Regulatory Affairs Manager

Regulatory Operations Manager (100% Remote, EST Time Zone) – 12-Month W2 Contract

Seeking an experienced Regulatory Operations Manager to oversee eCTD submission management across our client's product portfolio for global health authority submissions. This role ensures seamless coordination of publishing deliverables, oversees outsourced publishing and maintains submission quality and compliance.

Key Responsibilities:

• Manage electronic submissions (eCTD) and ensure compliance with regulatory agency standards
• Oversee outsourced publishing deliverables and ensure successful execution
• Serve as the primary regulatory point of contact throughout the product lifecycle
• Ensure submission timelines, quality standards, and expectations are met
• Conduct quality control checks on eCTD components, hyperlinks, and bookmarks
• Ensure submissions align with local health authority guidelines
• Utilize electronic document management and publishing tools effectively

Qualifications:

• 3-5 years of regulatory operations experience supporting US & Europe submissions
• Experience overseeing publishing vendors preferred
• Strong understanding of Health Authority guidelines and regulations