Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing at ISI1000ISIS

Department: Manufacturing & Operations - Ionis

Compensation

$93,200 – $186,749/yr

Setup: Remote, Hybrid
Location: Carlsbad, California
Type: Full-time
Level: lead/mgmt
Posted: Jul 22, 2026

Description

Ionis Pharmaceuticals is hiring an Assistant Director / Associate Director, Pharmaceutical Development – Regulatory Writing to author and coordinate CMC content for drug product regulatory submissions and supporting documents. The role translates formulation, manufacturing, analytical, stability, and control data into regulatory narratives; leads document planning, version control, review cycles, and submission readiness; and develops authoring workflows. It requires a relevant scientific degree and substantial drug product development experience, with sterile drug product development and regulatory CMC authoring experience preferred. The position offers onsite, hybrid, or remote work and pays $93,200 to $186,749 for the Assistant Director level or $156,216 to $190,120 for the Associate Director level.

Required Skills

CMC documents
Scientific writing
Document management
Project management
Sterile drug development
Regulatory submissions

Additional Information

Required Previous Experiences: Sterile drug product development and manufacture with CMC regulatory submission authoring
Authoring technical and administrative CMC documents in controlled documentation systems
Preferred Qualifications: Relevant scientific degree and 3–8 years of drug product development experience depending on degree level
Clear, accurate, and persuasive regulatory writing
Knowledge of FDA, ICH, USP, and ISO regulatory guidance
Common laboratory practices for drug product formulation and development
Organizational, project management, and communication skills