Director, Regulatory Writing – Remote Submissions Lead

Entrada Therapeutics; Boston (MA); On-site; USD 220,000 - 250,000; Full time

Benefits offered by this job

Health, dental and vision coverage

401(k) match

Parental leave (paid)

Education reimbursement

Discretionary time off

Commuting benefits

Job summary

Entrada Therapeutics in Boston seeks a Director of Regulatory Writing to coordinate high-quality regulatory documentation across preclinical through registration. You will lead authoring, liaise with external vendors, and drive submission readiness within a growing Regulatory Writing team.

The role requires a track record as a lead writer, strong project management, and collaboration with Regulatory Affairs and clinical teams. Located in Boston, on-site with a competitive benefits package.

Qualifications

• BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer.
• Strong work ethic, excellent communication skills, and a desire to work collaboratively with matrixed project teams.
• Experience with medical writing within pharma/biotech/CRO.
• Expertise with Microsoft Word and eCTD-compliant formatting requirements.
• Proficiency in organizing and interpreting complex scientific and clinical data.
• Experience with Duchenne muscular dystrophy or neuromuscular areas is a plus.

Responsibilities

• Plan and manage the authoring of regulatory submission components from preclinical through registration, including clinical protocols and amendments, IBs, DSURs, CSR, and submissions.
• Coordinate with external writing resources and internal contributors to ensure efficient execution.
• Serve as a lead author and document expert to maximize quality and efficiency of deliverables.
• Represent Regulatory Writing on cross-functional teams with subject matter experts and Program Management.
• Develop and maintain SOPs, authoring guides, and project management tools for regulatory writing.
• Collaborate with Regulatory Affairs to support submission-related activities.
• Build strong relationships with regulatory colleagues and cross-functional teams and external stakeholders.

Skills

Strong work ethic

Excellent communication skills

Collaborative with matrixed teams

Project management

Results-oriented mindset

Integrity

Growth mindset

Education

BS or MS in a scientific field

Tools

Microsoft Word

eCTD formatting

Job description

Entrada Therapeutics in Boston seeks a Director of Regulatory Writing to coordinate high-quality regulatory documentation across preclinical through registration. You will lead authoring, liaise with external vendors, and drive submission readiness within a growing Regulatory Writing team.

The role requires a track record as a lead writer, strong project management, and collaboration with Regulatory Affairs and clinical teams. Located in Boston, on-site with a competitive benefits package.