Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing

Scorpion Therapeutics; Carlsbad (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Excellent benefits

Job summary

Scorpion Therapeutics is seeking an Assistant Director / Associate Director for Pharmaceutical Development — Regulatory Writing to lead writing and coordination of CMC sections for regulatory submissions. You will translate complex formulation and manufacturing data into clear regulatory narratives and work with cross-functional teams to align messaging and timelines.

Responsibilities include planning, document integration, version control, and finalizing submission-ready CMC documents, plus

Qualifications

• 8+ years in drug product development and regulatory writing.
• Experience authoring CMC content for regulatory submissions.
• Clear, persuasive regulatory writing with scientific rigor.
• Experience with FDA/ICH/ISO guidance.
• Ability to manage controlled documentation systems.

Responsibilities

• Serve as primary author and/or coordinator for regulatory submissions.
• Translate technical data into regulatory narratives.
• Lead authoring strategy with cross-functional teams.
• Manage document planning, version control, review cycles, and finalization of CMC documents.
• Develop templates and workflows to improve consistency/efficiency/quality.
• Support process development of drug product manufacturing and formulation development as needed.

Skills

Regulatory writing

Cross-functional collaboration

Technical regulatory writing

Project management

Communication skills

Education

BA/BS in Pharmaceutical Sciences/Chemistry/Chemical Engineering/Biochemistry

MA/MS in related field

PhD (preferred)

Tools

Document management systems

Job description

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: https://ionis.com/careers).