Regulatory Affairs Generalist - Bridgewater, NJ

Published: 6/14/2022

Job Description

Job Description:
The Regulatory Affairs II (Reg II) – Generalist is responsible for reviewing, proofreading, and performing quality control of components for assigned FDA submissions to ensure the accuracy of documents for IND, NDA, and ANDA products. The role requires proficiency in Microsoft Word, Excel, Adobe Acrobat Pro, eCTD format requirements, and a Controlled Document Management System (preferably Documentum).

Key Responsibilities:

Review, proofread, and perform QC of assigned FDA submission components to ensure document accuracy.
Regulatory writing with a clear understanding and working knowledge of subject matter expert contributions (nonclinical, clinical, and medical affairs) for application components of identified filings.
Provide direct hands-on, highly operational, administrative regulatory writing support (e.g., cover letters, FDA forms, Module 1 documents).
Prepare and review content for submissions to INDs, NDAs, and ANDAs including annual reports, labeling, non-CMC supplements, and product correspondences.
Support authoring of subject matter expert-contributed Modular sections as identified.
Work with Regulatory Management to ensure all product documentation is developed in accordance with regulatory requirements; serve as designee as needed.
Support the preparation of documentation and materials required for interactions with Regulatory Authorities as assigned.
Provide final documents to Regulatory Operations for e-publishing and submission in eCTD format.
Communicate directly with and support Regulatory Product Leads and/or Director with assigned tasks.
Advise Regulatory Product Leads and/or Director of any delays in submissions or potential regulatory issues related to investigational and marketed products.
Perform other project-based tasks and/or special projects as assigned by Regulatory Management.

Knowledge and Skills:

Knowledge of regulatory affairs across the pharmaceutical product lifecycle, including development, labeling, and post-market requirements.
Knowledge of domestic and international laws, regulations, and guidance.
Knowledge of clinical development and managing development milestones and market authorization.
Ability to assess project risks and escalate appropriately.

Experience and Education Requirements:

Minimum Associate degree; Bachelor’s degree preferred or equivalent experience.
Minimum of 1.5 years of Regulatory Affairs experience or relevant experience in a regulated environment.