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
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.
* Assist in the preparation, revision and approval of labeling.
* Maintain and ensure all necessary logs (i.e. ADE) are complete
* Track NDA/ANDA commitments made to FDA to ensure commitments
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
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.