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Regulatory Affairs Associate - Senior Associate

Posted on 3.9.2014

ORGANIZATION STRUCTURE

The Regulatory Affairs Associate/Senior Associate position reports to the Manager of Regulatory Affairs. 

RESPONSIBILITIES 

Primary responsibilities of this role include the following:

  1. Prepares new ANDAs, NDAs and INDs
  2. Prepares responses to questions from Regulatory agencies with guidance
  3. Represent department as team members on interdisciplinary pre/post approval project teams with some guidance. Provide regulatory strategy as appropriate
  4. Reviews technical documents for submission in new ANDAs, NDAs and provides guidance to the technical development groups.
  5. Reviews change control requests for completeness and accuracy; assess impact of change with regards to the approved ANDAs and NDAs
  6. Under some guidance, formulate strategies to maintain submission goals
  7. Prepare supplements to support post approval changes and annual reports for approved ANDAs and NDAs.

QUALIFICATIONS

  • Minimum of a Bachelor’s degree in a science related discipline.
  • Minimum of 2-5 years of experience working in a Regulatory Affairs Department
  • Familiar with the preparation and maintenance of regulatory submissions
  • Understanding of eCTD submissions
  • Ability to manage timelines
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

GMP DECISION-MAKING AUTHORITY

Responsible for approval of GMP CMC documentation for ANDAs and NDAs.  Responsible for the approval of change controls and creation of change controls as necessary.