Associate Director, CMC Regulatory Affairs

Location: Onsite or hybrid; Carlsbad, California preferred, with remote work available

Salary: $181,162–$224,717 per year

Company

Ionis is a pharmaceutical company developing RNA-targeted medicines, gene-editing approaches, and therapies for serious diseases.

What you will do

• Develop and execute global CMC regulatory strategies for commercial compounds.
• Lead complex CMC submissions for new drug applications across US, Canada, EU, UK, MENA, LATAM, and APAC markets.
• Customize CTD sections, collect supporting documentation, and ensure submission quality, accuracy, and completeness.
• Manage CMC regulatory activities for partnered programs and coordinate with internal teams, partners, vendors, and subject-matter experts.
• Lead post-approval change assessments, variations, query responses, briefing documents, and commercial lifecycle maintenance.
• Support scientific advice and meetings with regulatory agencies while maintaining current knowledge of global regulations and guidance.

Requirements

• Bachelor’s degree in chemistry, biological sciences, engineering, or another scientific discipline; an advanced degree is preferred.
• At least 12 years of regulatory experience in the pharmaceutical industry.
• Experience preparing and delivering complex CMC regulatory submissions for new drug applications and post-approval changes across global markets.
• Strong knowledge of eCTD elements and structure, commercial lifecycle management, and cGMP operations.
• Proficiency with FDA, EU, ICH, USP, EP, JP, and other global regulatory requirements and guidelines.
• Experience interacting with regulatory agencies, strong regulatory writing skills, and the ability to manage multiple priorities independently.

Nice to have

• Advanced scientific degree.

Culture & Benefits

• Onsite, hybrid, and remote work environments are available.
• Collaborative work across regulatory, CMC, scientific, partner, and vendor teams.
• Opportunities to contribute to drug development and therapies for patients with unmet needs.
• Excellent benefits package.