Associate, Regulatory Operations and Submissions

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

Job summary

The Associate, Regulatory Operations and Submissions will assist with global regulatory submissions. Additionally, the Associate assist with ensuring compliant eCTD submissions and accurate, consistent and timely submission planning and tracking. The Associate will be responsible for formatting, publishing and QC at the document and submission level.

Essential job functions and duties

  • Responsible for document-level publishing, formatting, paper submissions compilation, and document quality control including: referencing, grammar/spelling/usage and style accuracy, check for consistency and mechanics.
  • Responsible for staying abreast of US, Harmonized (ICH) eCTD and ex-US guidances, and provide training as required.
  • Manages tracking of all submissions
  • Assists with publishing, review, submission and archive of eCTD submissions, including amendments and original filings.
  • Assists in developing Regulatory Operations standards and processes for paper and electronic publishing.
  • Assists in developing, updating, maintaining and disseminating information on Inovio’s submission processes and requirements.
  • Assists Regulatory Affairs and Clinical personnel with document level requirements and techniques for compliant upstream eCTD authoring

Minimum requirements

  • Bachelor’s degree or equivalent industry experience.
  • Minimum of 3 years of Regulatory Operations experience within the Pharmaceutical Industry.
  • Working knowledge and experience in regulatory submissions and product life cycle management.
  • Proficient in the use of common Microsoft software programs.
  • Familiarity and/or experience developing eCTD-compliant documents and submissions.
  • Familiarity with CTD, ICH, GCP, and other standards.
  • Ability to simultaneously plan, coordinate and lead activities on multiple projects.
  • Ability to self-direct workload, including reprioritizing and delivery under tight timelines.

Essential Requirements:

  • Excellent oral and written communication, interpersonal and organizational skills, and attention to detail
  • Ability to consistently meet tight timelines and deadlines
  • Ability to interact effectively with management and prioritize multiple projects
  • Technical proficiency, effective problem solving and critical thinking skills
  • Ability to work in in a team environment

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

 

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