Regulatory Operations Submissions Specialist

Location
Carlsbad, California
Posted
Jun 28, 2018
Ref
18-0153
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

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.

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.

RESPONSIBILITIES:

  • 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’ 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.

EDUCATION & EXPERIENCE REQUIREMENTS:

  • Bachelor's degree is required. Scientific field preferred.
  • 2-4 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. ISI Toolbox, Extedo eCTDManager, Veeva Vault etc.).
  • Extensive experience with Microsoft software such as MS Word and MS Excel.
  • Excellent oral and written communication skills.
  • An ability to be productive and successful in an intense work environment.

 

Excellent salary and benefits package offered.

Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition #18-0153

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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