Associate Director, CMC Regulatory Affairs — Global Submissions (Remote)

Ionis-Pharmaceuticals; Carlsbad (CA); Hybrid; USD 181,000 - 225,000; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds.

The role collaborates with cross-functional teams, partners, and vendors to deliver accurate regulatory documentation within timelines and to liaison with authorities for timely approvals. The candidate will lead complex submissions, oversee post-approval changes, and maintain current knowledge of applicable

Qualifications

• Experience leading global CMC regulatory submissions for US, Canada, EU, UK, and international regions.
• Strong regulatory writing and communication skills with attention to detail.
• Proven ability to manage multiple projects with aggressive timelines and deliverables.

Responsibilities

• Develop and execute global CMC regulatory strategies in collaboration with cross-functional teams and partners.
• Lead preparation of complex CMC regulatory submissions for new drug applications and post-approval changes across multiple regions.
• Coordinate regulatory activities, timelines, and interactions with health authorities to ensure timely approvals.
• Maintain up-to-date knowledge of FDA, EMA, MHRA, JP, CN, ICH guidelines and regulations.

Skills

Regulatory strategy

Global submissions

CMC knowledge

Cross-functional collaboration

Regulatory writing

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

eCTD knowledge

Regulatory databases

Job description

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds.

The role collaborates with cross-functional teams, partners, and vendors to deliver accurate regulatory documentation within timelines and to liaison with authorities for timely approvals. The candidate will lead complex submissions, oversee post-approval changes, and maintain current knowledge of applicable