Regulatory Affairs Associate I

Who we are

The opportunity

Under direct supervision, prepares regulatory submissions such as supplements, amendments to supplements and annual reports in accordance to FDA guidelines. The Associate I will be responsible for assisting in the evaluation of change controls as decided by the Manager or designee to assure accuracy of documents to be submitted.   In addition, he/she will accurately populate and maintain any/all Regulatory or team databases and trackers in real time, as directed by their Manager or designee.  Annual Report submission and all responsibilities associated will be the primary responsibility of the Associate I.

How you’ll spend your day

• Under direct supervision, prepare annual reports, and as experience is gained, assist in supplements for FDA submissions.


• Under direct supervision, review documents included as support to change controls (i.e. as side by side review of batch records, methods, specifications etc.) for adequate review of the quality and appropriateness of the change control.


• Familiarizing oneself with applicable FDA Regulation and guidance to learn about filing determinations as they are used on the change control process. 


• Other projects and duties as required/assigned.


• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual Reports.

Your experience and qualifications

• M. Pharma degree in RA/QA discipline, a plus.


• Minimum of two years Regulatory Affairs experience and/or analytical/QC, R&D/laboratory or production experience in pharmaceutical/biotech industry.


• Basic computer skills such as Word, Excel and familiarity with internet


• Ability to work independently and on teams


• Good verbal and written communication skills


• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

Reports To

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