Regulatory Affairs Associate

Website Aucta Pharmaceuticals, Inc.


Aucta Pharmaceuticals, Inc. is a technology-based company focusing on the development and commercialization of Branded Specialty Products. Aucta is a pharmaceutical company creating better products of proven molecules using 505(b)(2) regulatory pathway. Through innovation, Aucta is creating new therapeutics, including new dosage forms, new dosing regimens and new indications.


Regulatory Affairs Associate


Job Summary:

In alignment with organizational goals, support the business and the Regulatory Affairs team in day-to-day activities and the timely compilation and submission of INDs, NDAs, ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA.


Job Responsibilities:

  • Assist in dossier preparation and submission
  • Prepare label artworks for Package Insert, SPL submission, etc.
  • Write and edit technical documents to support regulatory submissions.
  • Assist in the development of regulatory strategy and update strategy based on regulatory changes.
  • Interface with a cross-departmental group of line functions, contract organizations and partners on a regular basis to ensure the project-specific regulatory strategy is met.
  • Prepares and reviews documents for submissions, including, but not limited to, meeting packages, petitions, INDs, NDAs, ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements and Deficiency Letter Responses.
  • Coordinated projects involving clinical/non-clinical studies.
  • Assists & prepares electronic files for inclusion in eCTD submissions. Prepare establishment registrations and drug listings including the submission of SPL via ESG/CDER Direct.
  • Prepare annual product review (APR) and batch release process for distributed products.
  • Manages document storage and records retention programs, with the ability to monitor on a regular basis to ensure proper disposition of physical and digital records

Required Competencies:

  • Strong scientific and technical background
  • Strong and proficient communication skills (written and verbal; persuasive technical writing).
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
  • Ability to read, analyze, and interpret scientific and technical Agency guidance.

Required Qualification(s) and Desired Experience:

  • BS in a science (preferably Biology, Chemistry, Pharmacy).
  • Minimum of 0-1 years of pharmaceutical industry experience.
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems.
  • Ability to learn new technology and apply it to business needs.


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