Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing

Assistant Director / Associate Director, Pharmaceutical Development — Regulatory Writing

Responsibilities

• Serve as primary author and/or coordinator for drug product CMC sections of regulatory submissions and supporting documents (INDs, IMPDs, NDAs, briefing packages, and responses to regulatory questions).
• Translate technical data (formulation, drug product/device development and manufacturing, analytical testing, stability, specifications, control strategies) into clear, accurate, phase-appropriate regulatory narratives.
• Partner with Pharmaceutical Development leads and cross-functional CMC teams to define authoring strategy, align messaging, identify data gaps early, and meet aggressive timelines.
• Lead document planning, content integration, version control, review cycles, comment reconciliation, and finalization of submission-ready CMC documents.
• Author and/or review technical documents supporting filings (development reports, justification documents, protocols, specifications, batch records, stability summaries, change assessments).
• Develop and standardize templates, best practices, and authoring workflows to improve consistency/efficiency/quality.
• Shape regulatory content for lifecycle changes, platform justifications, comparability arguments, and global expansion.
• Communicate with internal stakeholders, external partners, and vendors to obtain data and resolve issues.
• Support process development of drug product manufacturing and formulation development as needed.

Requirements

• BA/BS+ in Pharmaceutical Sciences/Chemistry/Chemical Engineering/Biochemistry or related field; 8+ years (BA/BS), 6+ years (MA/MS), or 3+ years (PhD) drug product development preferred.
• Sterile drug product development/manufacture experience; responsibility authoring CMC content for regulatory submissions.
• Clear, persuasive regulatory writing; strong scientific rigor.
• Experience authoring CMC technical and administrative documents within controlled documentation systems.
• Good judgment interpreting data and resolving risks/inconsistencies.
• Knowledge of FDA, ICH, USP, ISO and other relevant guidance.
• Competent in relevant laboratory practices.
• Excellent organizational, project management, and communication skills.

Benefits

Ionis provides an “excellent benefits package” (link: