Associate Director, Regulatory Writing – CMC Submissions

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Hybrid; USD 93,000 - 190,000; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, California, is seeking an experienced Pharmaceutical Development professional with a primary focus on CMC content for regulatory submissions.

This role will independently author, coordinate, and defend high-quality CMC content for global submissions while partnering with Regulatory CMC, Analytical, Quality, and Clinical teams. The successful candidate will drive efficient cross-functional collaboration, manage document planning, and ensure submission

Qualifications

• 8+ years of drug product development preferred (BA/BS).
• Experience in sterile drug product development and regulatory submissions (CMC).
• Strong writing, data interpretation, and communication for regulatory audiences.

Responsibilities

• Serve as primary author / coordinator for drug product CMC sections within regulatory submissions.
• Translate data into clear regulatory narratives and summaries.
• Lead authoring strategy, version control, and review cycles for submission-ready CMC documents.
• Develop templates, best practices, and workflows to improve quality and efficiency.

Skills

Regulatory writing

Cross-functional coordination

Document management

Attention to detail

Education

BS in Pharmaceutical Sciences

Tools

Document management systems

Job description

Ionis Pharmaceuticals, Inc. in Carlsbad, California, is seeking an experienced Pharmaceutical Development professional with a primary focus on CMC content for regulatory submissions.

This role will independently author, coordinate, and defend high-quality CMC content for global submissions while partnering with Regulatory CMC, Analytical, Quality, and Clinical teams. The successful candidate will drive efficient cross-functional collaboration, manage document planning, and ensure submission