Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

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 a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.

REGULATORY OPERATIONS SUBMISSIONS SPECIALIST

SUMMARY:

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 Sr. Manager, Regulatory Operations.

RESPONSIBILITIES:

• Format MS Word documents using software template tools and established standards.
• Publish PDF submission documents using standards for electronic submissions.
• Compile eCTD submissions.
• Prepare 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’ business needs.
• Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
• Contribute to new and updated processes and standards.
• Collaborate with other submission specialists within the Regulatory Operations team.
• Participate in validation testing of new and upgraded software.
• Responsible for the accuracy of information for submission metrics and registration information for senior management.

REQUIREMENTS:

• Extensive experience with MS 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 work experience.
• 1-2 years of experience in biotech industry is preferred.
• Experience with document management technology and electronic publishing software (e.g., Adobe, ISI Toolbox, Extedo eCTDManager, Veeva Vault, etc.) is desirable

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003120

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $58,770 to $74,660

NO PHONE CALLS, PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.