Director, Regulatory Writing

The role

The Director of Regulatory Writing will coordinate and lead the generation of high-quality regulatory documentation from preclinical through clinical and registration stages. This role involves leading authoring, managing external writing providers, and supporting documentation planning and submission activities.

What you will do

• Leads planning and management for authoring regulatory submission components from pre-clinical through registration phase.
• Manages external resources to ensure efficient execution of regulatory writing activities.
• Serves as a lead author and document expert for critical deliverables.
• Represents Regulatory Writing on cross-functional teams.
• Expands processes and standards including SOPs, authoring guides, and project management tools.
• Collaborates with Regulatory Affairs team to support submission-related activities.
• Develops working relationships with Regulatory colleagues, cross-functional project teams, and external stakeholders.

Required qualifications

• BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer
• Strong work ethic
• Excellent communication skills
• Demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry
• Expertise with Microsoft Word and eCTD-compliant formatting requirements
• Proficiency in organizing and interpreting complex scientific and clinical data
• Strong understanding of relevant ICH, GCP, and FDA regulatory standards
• Excellent project management skills
• Ability to work on multiple projects with tight timelines
• Motivated and driven attitude
• Proactive work style and results-oriented mindset
• Integrity, desire to learn and grow, and commitment to excellence

Nice to have

• Education in a scientific field
• Experience working within a biotech company while managing external resources
• Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways
• Experience within Duchenne muscular dystrophy or neuromuscular therapeutic areas

Benefits

• 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

About the company

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets. The company is advancing a development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases.