Regulatory Operations Specialist

  • Ascent
  • 201 E 45th St, New York, NY 10017
  • Full-Time

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Regulatory Operations Specialist


General Responsibilities

  • Assist in project management of NDA/IND activities

  • Provide regulatory support to clinical trial teams

  • Collect, coordinate, and prepare regulatory documentation for submission to regulatory agencies or to development partners

  • Complete submissions to FDA in collaboration with the Regulatory leads; including IND maintenance and safety reporting (this includes creating the cover letters and supporting documents)

  • Create, review and submit expedited Adverse Event Report submissions received from Pharmacovigilance to all active US INDs

  • Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.

  • Coordinate development and submission of annual Developmental Safety Update Report

  • Support Regulatory lead in NDA activities (i.e. meeting minutes, meeting planning, document review etc.)

Hopefully the person would have 3-5 years of experience in a regulatory/regulatory operations role.

- Experience working on an NDA team (preferably for an oncology product)

o Experience should not just be operational but should have actively participated on the NDA filing team

- Experience leading the development of an IND

Company Description:

About Ascent:

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.

If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

* 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.