Remote Director of Regulatory Writing: Lead Global Submissions

Regulatory Jobs; Boston (MA); On-site; USD 220,000 - 250,000; Full time

Job summary

Entrada Therapeutics is seeking a Director of Regulatory Writing in Boston to lead the creation of high-quality regulatory documents from preclinical through NDA. You will coordinate external writing resources, partner with Regulatory Affairs, and guide SOPs and study documents to ensure timely submissions.

The role requires a track record of lead writing across global development and strong project management.

Qualifications

• BS or MS with at least 7 years of increasing responsibility as a regulatory/medical writer.
• Experience leading regulatory writing for diverse development programs.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Lead planning and management for authoring regulatory submission components from preclinical through registration.
• Coordinate external writers and maintain effective communication with internal contributors.
• Serve as lead author and document expert to ensure high-quality deliverables.

Skills

Regulatory writing

Medical writing

Lead author

Project management

Cross-functional

Communication

Education

BS or MS in scientific field

Tools

Microsoft Word

eCTD formatting

Job description

Entrada Therapeutics is seeking a Director of Regulatory Writing in Boston to lead the creation of high-quality regulatory documents from preclinical through NDA. You will coordinate external writing resources, partner with Regulatory Affairs, and guide SOPs and study documents to ensure timely submissions.

The role requires a track record of lead writing across global development and strong project management.