Associate Director, CMC Regulatory Affairs

Job Category
:
Development
- Ionis

Requisition Number
: IONIS
004158

• Posted :
  October 9, 2026
• Full-Time

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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!

This individual’s primary responsibility will be to establish and execute global CMC regulatory strategies for commercial compounds in Ionis’ product pipeline. This is a team and individual contributor role, reporting to the Director, CMC Regulatory Affairs. This individual will collaborate and coordinate cross-functionally at Ionis, and with partner companies and vendors, to complete accurate and compliant regulatory documentation and ensure all regulatory requirements are met according to established timelines.

The successful candidate will be able to: (1) understand and fulfill complex CMC requirements for global submissions, (2) work independently to manage projects and deliver output in a timely manner with limited supervision, (3) provide CMC regulatory leadership within Regulatory Affairs and on cross-functional teams, (4) serve as a liaison between regulatory authorities and the company regarding CMC issues to ensure timely approvals, (5) manage progress and completion of responsibilities to ensure delivery of CMC regulatory submissions in accordance with health authority deadlines, established departmental goals and objectives, and project plans and milestones, and (6) maintain current knowledge and expertise of relevant FDA, EMA, MHRA, JP, CN, and ICH guidelines and regulations.

onsite/hybrid
- Carlsbad, CA preferred; open to remote

• Develop and execute global CMC regulatory strategies in collaboration with CMC RA colleagues and CMC subject matter experts in an environment committed to the efficient and aggressive development and commercialization of new drugs for patients
• Lead the preparation of complex CMC regulatory submissions for new drug applications in US, Canada, EU, UK, MENA, LATAM, and APAC regions by navigating and fulfilling regional regulatory requirements, customizing CTD sections, and collecting…