Position: Regulatory Affairs Specialist
Status: Exempt, Salaried
Reports to: Vice President of Regulatory Affairs
- Prepare submissions for New Drug and Abbreviated New Drug Applications (NDAs and ANDAs) according to ICH-CTD.
- Develop and assess strategies for regulatory approvals for NDAs and ANDAs by providing input for product development through commercialization.
- Prepare controlled correspondence with FDA
- Communicate with FDA project manager on NDA and ANDA related issues
- Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.
- Review of documents and interacting with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation utilizing the change control database to ensure accurate reporting to FDA.
- Assist in maintaining approved NDA/ANDAs current by requesting revisions to technical documentation as part of the annual report preparation process.
- Provide a critical detailed review of technical documentation including labeling, distribution reports, analytical procedures, product specifications, manufacturing and packaging batch records, in-process specifications, etc. prior to FDA submission.
- Assist in the preparation, review and submission of amendments and supplements to NDA and ANDAs.
- Track NDA/ANDA commitments made to FDA to ensure commitments are completed and reported in a timely manner.
- Maintain and ensure all NDA/ANDA documentation is filed properly.
- Maintain and manage product specific checklists to ensure that all required documentation and information is available, accurate and complete for submission.
- Assist in the preparation and submission of required post approval reports such as field alert reports, periodic adverse drug experience reports etc.
- Maintain current knowledge of FDA regulations and guidance’s pertaining to changes to approved regulatory applications.
- Strong knowledge and understanding of CMC.
- Knowledge of USP, Code of Federal Regulations, FDA/ICH guidance’s and the regulatory process pertaining to drug development and approval.
- Ability to read and interpret complex technical documents. Ability to write comprehensive reports. Strong computer skills.
- Physical activities include, but are not limited to, repetitive motions. Substantial movements (motions) of the wrists, hands, and/or fingers.
- The physical requirement is sedentary. Exerting up to 10 lbs. of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Sedentary works involves sitting most of the time. Walking and standing are required only occasionally.
- The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
- The employee is not substantially exposed to adverse environmental conditions