Director, Regulatory Affairs

Assistant Director / Associate Director, Pharmaceutical Development ? Regulatory WritingIonis Pharmaceuticals is seeking an experienced Pharmaceutical Development professional with a primary focus on preparation of CMC documents in support of development and late-stage drug product programs. This role is well-suited for an individual who can independently author, coordinate, and defend high-quality CMC content for global regulatory submissions and internal reports, while partnering closely with Pharmaceutical Development, Analytical, Quality, Regulatory CMC, Clinical Supply, Device, Project Management, and external stakeholders.The ideal candidate will bring strong technical expertise in drug product development, along with excellent scientific writing, cross-functional coordination, and document management skills. This position will focus primarily on dossier and report authoring, with occasional support for routine laboratory execution or other departmental activities as needed. The ability to interpret development, manufacturing, analytical, and stability data with scientific rigor and sound judgment is essential.The successful candidate will drive progress by synthesizing complex technical information quickly to produce polished regulatory documents that accurately communicate the technical information with strategic clarity. They will proactively elevate the quality and efficiency of CMC authoring across Pharmaceutical Development programs to ensure submissions are accurate, complete, and on time.Responsibilities:Serve as the primary author and/or coordinator for drug product CMC sections of regulatory submissions and supporting documents, including INDs, IMPDs, NDAs, briefing packages, and responses to regulatory questions.Translate technical data from formulation development, drug product/device development and manufacturing, analytical testing, stability studies, specifications, and control strategies into clear, accurate, phase-appropriate regulatory narratives and summaries.Partner with Pharmaceutical Development leads and cross-functional CMC teams to define authoring strategy, align messaging across drug product sections, identify data gaps early, and drive document completion within aggressive timelines.Lead document planning, content integration, version control, review cycles, comment reconciliation, and finalization of submission-ready CMC documents.Author and/or review related technical documents that support regulatory filings, such as development reports, justification documents, protocols, specifications, batch records, stability summaries, and change assessments.Develop and standardize templates, best practices, and authoring workflows that improve consistency, efficiency, and quality across multiple concurrent programs.Contribute strategically to late-stage and commercial readiness activities by helping shape regulatory content for lifecycle changes, platform justifications, comparability arguments, and global expansion efforts.Communicate effectively with internal stakeholders, external partners, and vendors to obtain data, resolve issues, and keep submission activities moving forward.Support process development of drug product manufacturing and formulation development for early stage and late-stage drug products as needed.Requirements:BA/BS or higher degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline with a minimum of 8 years (BA/BS), 6 years (MA/MS), or 3 years (PhD) drug product development experience is preferred.Experience in sterile drug product development and manufacture with responsibility authoring CMC content for regulatory submissions.Ability to write clearly, accurately, and persuasively for regulatory audiences while maintaining scientific rigor and presentation clarity.Experience authoring technical and administrative CMC documents and working within controlled documentation systems.Good judgment in interpreting data, identifying risks or inconsistencies, and facilitating practical resolutions to support submission quality and timelines.Knowledgeable in FDA, ICH, USP, ISO and other relevant regulatory guidance applicable to pharmaceutical development and CMC submissions.Competent in common laboratory practices relevant to drug product formulation and development.Excellent organizational, project management, and communication skills, with the ability to manage multiple time-sensitive deliverables independently.