Regulatory Submissions Associate

Bachelor’s degree in chemistry or related science
Atlanta, GA 30318 US (Primary)
Career Level:
Experienced (Non-Manager)
Regulatory Submissions
Job Type:
Job Description:

The Regulatory Submissions Associate for Mikart, Inc. assists in the preparation of regulatory submissions to the FDA for unapproved INDs, NDAs, ANDAs, supplements and amendments.

Duties to include:

  • Act as regulatory project lead by coordinating workflow and adherence to timelines related to submissions on assigned projects.
  • Maintain current knowledge of FDA regulations and guidance’s related to CMC and ANDA filings, including CTD and electronic formats.  Review regulations for NDA and IND filings as
  • Compile and review documents for CMC/ANDA/NDA/IND submissions, including all relevant data, procedures, specification sheets and method validation reports.
  • Coordinate, prepare, review and file original applications, CMC sections, amendments, deficiency responses, supplements, and annual reports.
  • Create draft Citizen’s Petition packages for consulting firm, as needed.
  • Communicate and coordinate with other departments to expedite document flow.
Job Requirements:

A Bachelors degree in chemistry or related science and 2 to 4 years of experience in a GMP environment, or other appropriate combination of education and experience.  Must display attention to detail, excellent organizational skills and the ability to handle multiple priorities. Well developed technical writing skills, along with the ability to work under minimal supervision in a team environment and effectively communicate with other departments, is required.  Knowledge of ANDA submissions and pharmaceutical manufacturing is a plus.

Apply and Submit Resume/CV.