Regulatory Affairs Manager II

TalentBurst; Cambridge (MA); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading company is seeking a Regulatory Affairs Manager II to oversee eCTD submissions and coordinate publishing deliverables. This role requires expertise in regulatory functions and quality control, with a focus on ensuring compliance with health authority guidelines. The position is fully remote, making it ideal for candidates in the EST time zone.

Qualifications

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

Responsibilities

• Manage eCTD submissions for global development.
• Coordinate publishing deliverables and oversee outsourcing.
• Ensure compliance with health authority guidelines.

Skills

Regulatory Affairs

Quality Control

Project Management

Tools

eCTD

Electronic Document Management

Job description

Regulatory Affairs Manager II

Location: EST time preferred, potentially central, but not West Coast. 100% Remote (EST time zone). Duration: 12 months+

Responsibilities:

1. Manage eCTD submissions across the company's product portfolio to Health Authorities for global development and lifecycle management.
2. Coordinate all publishing deliverables in line with strategic program/product directions. Oversee outsourced publishing to ensure successful operational execution.
3. Serve as the primary contact for regulatory functions throughout the product lifecycle, ensuring submission deliverables are accessible to all stakeholders.
4. Ensure timely handoffs from the authoring community, maintaining adherence to submission standards and quality expectations.
5. Drive deliverable timelines, set standards for quality, and ensure electronic submissions meet regulatory and client requirements.
6. Perform quality control on electronic components, final submissions, hyperlinks, and bookmarks, ensuring compliance with local health authority guidelines.
7. Demonstrate expertise in submission processes and relevant health authority regulations.
8. Proficient in electronic document management and submission publishing tools.

Qualifications:

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