Job Description

Title: Senior Associate of Regulatory Operations/CMC

Summary:

A leading, global pharmaceutical client of ours is looking to hire a Senior Associate of Regulatory Operations and CMC, based out of their New Jersey office. This rapidly growing client has drug products spanning generics, branded prescriptions, and injectables. This role will specifically focus within the client's generic portfolio which covers oncology, cardiology, respiratory, and neurology. The main function of the Senior Associate of Regulatory Operations/CMC is to plan, coordinate, and prepare regulatory submissions to be compliant with FDA and ICH requirements. This role will give you a great opportunity to contribute to the company's mission of producing high-quality and accessible medicines for all.

The Sr. Associate will be responsible for...

• Prepare and publish U.S. regulatory submissions to the FDA, including NDAs, INDs, ANDAs, Amendments, Supplements, and Annual Reports.
• Collaborate with managers and document authors to develop and maintain a comprehensive set of e-submission document templates.
• Ensure efficient tracking, archiving, and storage of regulatory records in both electronic and hard copy formats.
• Manage all aspects of document work flows related to submission authoring, review, compilation, and publishing for various submission types.
• Assist in the development, authoring, and refinement of SOPs and Work Instructions for the Publishing and Electronic Submission Management System.
• Maintain and update trackers, spreadsheets, and databases with accuracy and timeliness.

The Sr. Associate should have the following qualifications:

• Bachelor's degree in a life science discipline. Advanced degree preferred.
• Minimum of 5 years in pharmaceutical industry with 3-4 years in regulatory affairs
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge of eCTD publishing systems and US FDA (OGD/CDER) e-submission requirements

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