Global CMC Regulatory Director - Remote/Hybrid

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

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for CMC across the product pipeline. You will collaborate with cross-functional teams and external partners to deliver compliant submissions on aggressive timelines.

The role requires deep experience with FDA/EMA guidance, eCTD submissions, and lifecycle management, driving high-quality regulatory outcomes and timely approvals worldwide.

Qualifications

• Bachelor’s Degree in a scientific discipline; advanced degree preferred.
• Minimum 12 years of regulatory experience in the pharmaceutical industry.
• Strong knowledge of FDA, EMA, ICH guidelines and cGMP.

Responsibilities

• Develop and execute global CMC regulatory strategies for Ionis’ pipeline.
• Lead preparation of complex CMC submissions for US, Canada, EU, UK, MENA, LATAM and APAC.
• Coordinate cross-functional teams to ensure timely submissions and approvals.
• Drive post-approval changes and lifecycle maintenance across markets.
• Support meetings with regulatory agencies to resolve CMC issues.

Skills

Regulatory writing

Project management

Cross-functional collaboration

Regulatory strategy

FDA/EMA guidelines

Communication

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

eCTD concepts

AI tools to support tasks

Job description

Ionis Pharmaceuticals, Inc. seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for CMC across the product pipeline. You will collaborate with cross-functional teams and external partners to deliver compliant submissions on aggressive timelines.

The role requires deep experience with FDA/EMA guidance, eCTD submissions, and lifecycle management, driving high-quality regulatory outcomes and timely approvals worldwide.