Ionis Pharmaceuticals, Inc.
Regulatory Operations Submissions Specialist
General Job Description:
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 and was purposely designed to create a better, more efficient drug discovery platform, establish a new innovation-centered business model, and maximize the value of every medicine created and get it to the people who need it most as quickly and as efficiently as possible.
With the RNA molecule as the basis of our novel drug discovery platform, we are targeting an unprecedented range of therapeutic areas. Our antisense therapies are disrupting diseases and changing their course—from the rarest of conditions, to those that impact millions of people. We currently have three commercial products and more than 40 potentially transformative medicines in our pipeline designed to treat a broad range of diseases.
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.
REGULATORY OPERATIONS SUBMISSIONS SPECIALIST
The Submissions Specialist is responsible for the formatting (Word), publishing (PDF), eCTD compilation, review and dispatch of regulatory submissions to global Health Authorities within required timeframes. This is an individual contributor position, reporting to the Manager, Regulatory Operations.
Format and publish regulatory submissions, ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
Collaborate with interdepartmental teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet Ionis’s business needs.
Compile submissions into the eCTD format.
Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
Review R&D documents to ensure compliance with company submission standards.
Contribute to new and updated processes and standards.
Participate in validation testing of new and upgraded software.
Responsible for the accuracy of information for submission metrics and registration information for senior management.
Extensive experience with Microsoft Word to prepare technical documents.
Excellent oral and written communication skills.
Demonstrated ability to be productive and successful in an intense work environment.
Bachelor's degree or equivalent experience.
1-2 years of experience in biotech industry is preferred.
Experience using MS Word 3rd party plugins (such as Starting Point Authoring tool, ISI Writer, other template software or EndNote Reference software) is preferred.
Experience with document management technology and electronic publishing software (e.g.ISI Toolbox, Extedo eCTDManager, Veeva Vault etc.) is highly desirable.
Excellent salary and benefits package offered.
Application Information & Contact (How to Apply)
Please visit the Ionis website, for more information about Ionis and to apply for this position; reference requisition # REGUL01852
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.