Director, Regulatory Writing

TScan Therapeutics

. Lead planning and management of regulatory submission components from preclinical through registration phases .

Posted 11/4/2026full-timeRemote • Massachusetts • United StatesLead💰 $220,000 - $249,711 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory writing and management of submission components, with a strong understanding of ICH, GCP, and FDA standards. Proven ability to coordinate cross-functional teams and manage multiple projects effectively while maintaining high-quality documentation.

Highest-signal resume keywords

Regulatory WritingClinical Protocol DevelopmentECTD-Compliant FormattingProject ManagementMedical Writing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission ManagementClinical Study Report AuthoringData InterpretationSOP DevelopmentClinical Documentation

Soft Skills

Excellent Communication SkillsCollaborative ApproachProactive Work StyleResults-Oriented MindsetStrong Work Ethic

Tools & Technologies

Microsoft WordProject Management Tools

Industry Keywords

Pharmaceutical IndustryBiotech IndustryCRO IndustryICH StandardsFDA Regulatory StandardsRare DiseasesPediatricsGenetic MedicinesExpedited Development PathwaysDuchenne Muscular Dystrophy

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead planning and management of regulatory submission components from preclinical through registration phases
Author or coordinate clinical protocols and amendments, Investigator's Brochures, Development Safety Update Reports, clinical study reports, health authority meeting requests and briefing documents, and IND, CTA, CTR, and NDA summary documents
Manage external resources and coordinate communication with internal contributors and stakeholders
Serve as lead author and/or document expert for critical deliverables
Represent Regulatory Writing on cross-functional teams with subject matter experts, Regulatory Affairs, and Program Management
Develop, maintain, and improve SOPs, authoring guides, and project management tools
Support submission-related activities with Regulatory Affairs
Build relationships with Regulatory colleagues, cross-functional project teams, and external stakeholders to achieve timelines and portfolio deliverables

Requirements

What you’ll need

BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer
Education in a scientific field is a plus
Demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry, particularly creating and updating clinical development documentation
Experience managing external resources is a plus
Expertise with Microsoft Word and eCTD-compliant formatting requirements
Proficiency organizing and interpreting complex scientific and clinical data
Strong understanding of ICH, GCP, and FDA regulatory standards governing regulatory documentation
Experience with rare diseases, pediatrics, genetic medicines, or expedited development pathways is strongly preferred
Experience in Duchenne muscular dystrophy or neuromuscular therapeutic areas is a plus
Excellent project management skills and ability to work on multiple projects with tight timelines
Strong work ethic, excellent communication skills, collaborative approach, proactive work style, results-oriented mindset, integrity, desire to learn and grow, and commitment to excellence

Benefits

Comp & perks

Comprehensive health, dental and vision coverage
Life and disability insurance
401(k) match
Paid, gender-inclusive parental leave
Holistic support for health and well-being
Education reimbursement
Discretionary time off
Commuting benefits aligned to the working model