Manager, CMC Regulatory Affairs
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
Manager, CMC Regulatory Affairs
This individual’s primary responsibility will be to manage and execute CMC regulatory requirements for all clinical and commercial compounds in Ionis’ product pipeline. This individual will collaborate and coordinate cross-functionally and with partner companies and vendors to complete accurate and compliant regulatory documentation, and to ensure all regulatory requirements are met according to established timelines. The successful candidate will possess strong project management skills; maintain current knowledge and expertise of relevant FDA, EMA, and other global guidelines and regulations; and ensure progress and completion of responsibilities in accordance with established departmental goals or project plans.
- Ensure the quality, accuracy, and completeness of CMC sections within all regulatory filings, amendments, and updates
- Manage the change control process for US and global regulatory filings
- Maintain forecasted submission timelines in support of all assigned programs and ensure compliance with the established timelines
- Confirm compliance of Ionis’ manufacturing and testing activities with respect to Ionis procedures and FDA, EMA, ICH, USP, EP, JP, and other regulatory guidelines
- Provide regulatory review of new and revised material specifications and stability testing protocols
- Review and approve SOPs that have potential regulatory impact or that otherwise require regulatory approval
- Maintain Accreditation of Foreign Manufacturers with PMDA
- Evaluate relevant facility, manufacturing, and analytical change controls for regulatory impact, and perform any required notifications, variances, or updates
- Coordinate external or outsourced regulatory operations with partners and vendors
- Support the development, review, and approval process for commercial and clinical packaging and labeling operations
- Bachelor’s Degree in a scientific discipline (e.g., chemistry, biological sciences, engineering, etc.)
- Minimum of 4 years of regulatory experience in the pharmaceutical industry. Prior experience interacting with regulatory agencies is a plus
- This individual will have and maintain proficiency in FDA, EU, ICH, USP, EP, JP, and other global requirements and guidelines related to regulatory submissions and cGMP operations
- Strong knowledge of eCTD elements and structure, proficient regulatory writing skills, and experience related to clinical and commercial CMC regulatory submissions is essential
- Strong effective communication, interpersonal, and teamwork skills, and must be able to manage multiple priorities with aggressive timelines at a high level of productivity and proficiency
Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #17-0119
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.