Associate Director, CMC Regulatory Affairs
Ionis Pharmaceuticals, Inc.
Summary
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.
Job description
Responsibilities
- Develop and execute global CMC regulatory strategies in collaboration with CMC RA colleagues and CMC subject matter experts
- Lead the preparation of complex CMC regulatory submissions for new drug applications in US, Canada, EU, UK, MENA, LATAM, and APAC regions
- Lead CMC regulatory aspects of partnered programs to ensure overall CMC strategy is achieved
- Prepare, communicate, and drive timelines to ensure delivery of CMC regulatory submissions
- Facilitate timely regulatory approvals of new drug applications by ensuring quality, accuracy, and completeness of submissions
- Understand and fulfill CMC post-approval regulatory activities for commercial products
- Participate in cross-functional teams to lead timely preparation of high-quality regulatory submissions
- Support scientific advice / meetings with regulatory agencies to resolve CMC issues
- Maintain knowledge of current and emerging regulatory legislation/guidance impacting CMC requirements
Competencies Identified for Success
- Proven functional expertise with preparation and execution of CMC regulatory strategies and submissions for global markets
- Strong and effective communication (verbal and written), interpersonal, and teamwork skills
- Action-oriented, with ability to efficiently manage multiple priorities with aggressive timelines
- Detail-oriented, with proficient regulatory writing skills
- Ability to work effectively and collaboratively towards a shared goal
- Ability to work independently to manage projects and deliver output in a timely manner with limited supervision
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
Benefits
- Competitive benefits package
Company overview
Ionis Pharmaceuticals, Inc. is a pioneering commercial-stage biotechnology company that specializes in discovering and developing RNA-targeted medicines. Founded in 1989 and headquartered in Carlsbad, California, Ionis has established itself as a leader in antisense therapy, RNA interference, and CRISPR therapeutics. The company's innovative approach focuses on modifying RNA to treat a wide range of serious diseases, including neurological disorders, cardiovascular conditions, and rare genetic diseases. Ionis has developed several FDA-approved therapies, including SPINRAZA for spinal muscular atrophy, TRYNGOLZA for familial chylomicronemia syndrome, WAINUA for hereditary transthyretin-mediated amyloidosis, and QALSODY for amyotrophic lateral sclerosis. With a robust pipeline of over 40 investigational medicines in various stages of development, Ionis maintains strategic collaborations with major pharmaceutical companies like Biogen, AstraZeneca, Novartis, and Roche. The company employs approximately 1,069 professionals and continues to advance its mission of delivering transformative medicines that enable better futures for patients living with serious diseases.