Associate Director, Regulatory Writing – CMC (Remote)

JobRx, Inc.; Carlsbad (CA); On-site; USD 93,000 - 190,000; Full time

Benefits offered by this job

Full Benefits

Job summary

Ionis Pharmaceuticals, Inc. is seeking an experienced Pharmaceutical Development professional with a primary focus on preparing CMC documents for regulatory submissions.

The role requires independent authoring, coordinating, and defending high-quality CMC content while partnering with multiple internal teams and external stakeholders. The ideal candidate will have strong technical expertise in drug product development, excellent scientific writing, and the ability to manage complex regulatory

Qualifications

• 8+ years BA/BS drug product development experience preferred.
• Experience in sterile drug product development and CMC regulatory submissions.
• Ability to write clearly, accurately, and persuasively for regulatory audiences.
• Experience authoring technical and administrative CMC documents in controlled systems.
• Knowledge of FDA, ICH, USP, ISO and related regulatory guidance.
• Strong organizational, project management and communication skills.

Responsibilities

• Serve as primary author or coordinator for drug product CMC sections of regulatory submissions.
• Translate technical data into clear regulatory narratives and summaries.
• Define authoring strategy with cross-functional CMC teams and drive timelines.
• Lead document planning, version control, reviews and submission finalization.
• Author or review development reports, specifications, stability summaries, and change assessments.
• Develop templates, best practices, and workflows for consistency and quality.

Skills

Regulatory writing

Cross-functional coordination

Project management

Regulatory guidance knowledge

Clear scientific writing

Education

BA/BS or higher in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or related field

Job description

Ionis Pharmaceuticals, Inc. is seeking an experienced Pharmaceutical Development professional with a primary focus on preparing CMC documents for regulatory submissions.

The role requires independent authoring, coordinating, and defending high-quality CMC content while partnering with multiple internal teams and external stakeholders. The ideal candidate will have strong technical expertise in drug product development, excellent scientific writing, and the ability to manage complex regulatory