Associate Director, CMC Regulatory Affairs

Ionis•Carlsbad, CA

4d•Hybrid

About The Position

Ionis Pharmaceuticals, Inc. is seeking an Associate Director, CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds in Ionis’ product pipeline. This role involves both team and individual contributions, reporting to the Director, CMC Regulatory Affairs. The position requires collaboration and coordination across Ionis departments, as well as with partner companies and vendors, to ensure accurate and compliant regulatory documentation and adherence to timelines. The successful candidate will be adept at understanding and fulfilling complex global CMC requirements, managing projects independently, providing CMC regulatory leadership, liaising with regulatory authorities, managing submission progress, and staying current with relevant global guidelines and regulations.

Requirements

Bachelor’s Degree in a scientific discipline (e.g., chemistry, biological sciences, engineering) required; advanced degree preferred
Minimum of 12 years of regulatory experience in the pharmaceutical industry
Successful experience interacting with regulatory agencies
Demonstrated ability to prepare and deliver complex CMC regulatory submissions for new drug applications and post-approval changes/variations in US, Canada, EU, UK, MENA, LATAM, and APAC regions
Strong knowledge of eCTD elements and structure
Strong knowledge of commercial lifecycle management requirements
Proficiency in FDA, EU, ICH, USP, EP, JP, and other global requirements and guidelines related to regulatory submissions and cGMP operations
Demonstrated ability to leverage artificial intelligence tools as an aid to support and enhance the execution of complex tasks, prepare presentations, and improve efficiency

Nice To Haves

Advanced degree preferred

Responsibilities

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 necessary ancillary documents
Lead CMC regulatory aspects of partnered programs to ensure overall CMC strategy is achieved and to ensure delivery of required regulatory support and submissions
Prepare, communicate, and drive timelines to ensure delivery of CMC regulatory submissions in accordance with health authority deadlines, established departmental goals and objectives, and project plans and milestones
Facilitate timely regulatory approvals of new drug applications by ensuring the quality, accuracy, and completeness of submissions
Understand and fulfill CMC post-approval regulatory activities for commercial products by assessing regulatory impact of manufacturing change controls, preparing post-approval changes/ variations, and performing lifecycle maintenance across global markets
Participate in cross-functional teams to lead the timely preparation of high-quality regulatory submissions (including initial NDAs, post-approval changes/variations, query responses, and briefing documents)
Support scientific advice / meetings with regulatory agencies to resolve CMC issues and ensure efficient drug development and drug approval
Maintain knowledge of current and emerging regulatory legislation/guidance impacting CMC requirements