Regulatory Affairs Manager II

TalentBurst, an Inc 5000 company; Cambridge (MA); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company is seeking a Regulatory Affairs Manager II to oversee eCTD submissions and ensure compliance with health authority guidelines. This role involves managing publishing deliverables and coordinating with stakeholders for product lifecycle management. The position is fully remote, requiring expertise in regulatory operations and electronic document management.

Qualifications

• 3-5 years of regulatory operations experience.
• Experience managing publishing vendors preferred.

Responsibilities

• Manage eCTD submissions for global development.
• Coordinate publishing deliverables with strategic goals.
• Perform quality control checks on electronic components.

Skills

Regulatory Operations

Quality Control

Project Management

Tools

Electronic Document Management

Publishing Tools

Job description

Regulatory Affairs Manager II

EST time preferred) - Maybe central, but not west coast.

100% Remote (EST time zone)

12 months+

Responsibilities

• Manage eCTD submissions across the company's product portfolio to health authorities for global development and lifecycle management.
• Coordinate all publishing deliverables in line with strategic program goals. Oversee outsourced publishing to ensure successful operational execution.
• Serve as the primary regulatory contact for product lifecycle, ensuring submission deliverables are integrated and accessible to stakeholders.
• Ensure timely handoffs from the authoring team, adhering to submission standards and quality expectations.
• Drive timelines with the Regulatory Submission Manager and authoring teams, maintaining standards for electronic submissions and documentation.
• Perform quality control checks on electronic components, hyperlinks, bookmarks, and ensure compliance with regulatory guidelines.
• Maintain expert knowledge of relevant health authority guidelines and regulations.
• Proficient in electronic document management and publishing tools.

Qualifications:

3-5 years of regulatory operations experience supporting submissions in the US and Europe. Experience managing publishing vendors is preferred.