Regulatory Submissions Publishing Lead (eCTD)

Adweek; Bridgewater (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Artech is seeking a Regulatory Affairs Operations submissions specialist to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. You will ensure compliance with ICH/FDA regulations, manage submission workflows, and dispatch through the FDA Gateway in a fast-paced, highly regulated environment.

The role requires experience in publishing capabilities across eCTD backbone and related modules, with a focus on quality and timely delivery of submissions to

Qualifications

• Bachelor degree or equivalent in regulatory affairs, the sciences, or related field.
• Four years submission publishing experience.
• Experience with regulatory submissions and FDAICH regulations (ICH and FDA regulations).

Responsibilities

• Publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads.
• Coordinate publishing tasks for assigned submissions, including peer review.
• Ensure adherence to SOPs, guidance documents and policies throughout submissions lifecycle.
• Archive submissions electronically and in paper form.
• Dispatch submissions through the FDA Gateway and ensure timely delivery.

Skills

Autonomous in matrix environment

Analytical and decision-making skills

Interpersonal skills

Regulatory knowledge

Ability to multi-task

Adaptability to change

Education

Bachelor’s degree in regulatory affairs or related field

Tools

MS Office

Adobe Professional

Adobe Add-ins

Publishing Software (sCubed / eCTD Manager)

Validation Tools

Document Management Systems

eCTD Manager

Job description

Artech is seeking a Regulatory Affairs Operations submissions specialist to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. You will ensure compliance with ICH/FDA regulations, manage submission workflows, and dispatch through the FDA Gateway in a fast-paced, highly regulated environment.

The role requires experience in publishing capabilities across eCTD backbone and related modules, with a focus on quality and timely delivery of submissions to