The Regulatory Affairs Associate/Senior Associate position reports to the Manager of Regulatory Affairs.
Primary responsibilities of this role include the following:
- Prepares new ANDAs, NDAs and INDs
- Prepares responses to questions from Regulatory agencies with guidance
- Represent department as team members on interdisciplinary pre/post approval project teams with some guidance. Provide regulatory strategy as appropriate
- Reviews technical documents for submission in new ANDAs, NDAs and provides guidance to the technical development groups.
- Reviews change control requests for completeness and accuracy; assess impact of change with regards to the approved ANDAs and NDAs
- Under some guidance, formulate strategies to maintain submission goals
- Prepare supplements to support post approval changes and annual reports for approved ANDAs and NDAs.
- 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.