Job Description:

Temporary Contract, 6 Months

We are seeking an experienced, Regulatory Operations professional who can assist with a variety of submissions and operational activities with limited supervision.

Requirements:
  • 5+ Years of eCTD publishing experience (global eCTD filing experience preferred).
  • Responsible for both Submission and Document Level Publishing.
  • Experience with CTA submissions desired.
  • Responsible for the creation, assembly, and publishing of global electronic submissions, including MAAs/NDAs, INDs, CTAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
  • Knowledge of health authority procedures/guidance's regarding electronic submissions required.
  • May interface with project managers, regulatory product managers, and or content authors to discuss submission preparation.
  • Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
  • Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
  • Liaise with functional source areas to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
  • Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
  • Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

Qualification:

  • Knowledge of industry trends regarding electronic submissions.
  • Proficiency with MS-Office Suite and Adobe Acrobat applications.
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Excellent organization, written/verbal communication, and attention to detail
  • Knowledge of health authority procedures/guidance's regarding electronic submissions.
  • Knowledge of Electronic Document Management Systems.
  • Ability to balance multiple tasks to meet priorities and timelines.
  • Strong attention to detail.


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

Launch your career - Upload your resume now!

Upload your resume

Loading some great jobs for you...