Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing

Ionis; 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

Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

SUMMARY

Ionis 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.

Ionis Benefits

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

The pay scale for this position is $93,200 to $186,749

The pay scale for the Assistant Director position is $93,200 to $186,749

The pay scale for the Associate Director position is $156,216 to $190,120

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.

Ionis offers an excellent benefits package! Follow this link for more details: