Senior Associate , Regulatory Operations CMC at The Judge Group Inc. in Morristown, New Jersey

Job Description:

Location: Morristown, NJ

Salary: $100,000.00 USD Annually - $115,000.00 USD Annually

Description: Our client is currently seeking a Senior Associate , Regulatory Operations CMC



This job will have the following responsibilities:

Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time.

Works with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.

Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.

Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.

Assists in monitoring and maintaining familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensuring that all functional disciplines are apprised of the changes and trained accordingly.

Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Submission Management System.

Independently tracks and manages all correspondence between company and government agencies, including phone calls, emails, and relevant documents.

Accurately updates and maintains trackers, spreadsheets and databases in a timely manner.

Qualifications & Requirements:

Minimum of a Bachelor's Degree in a life science. Advanced degree preferred.

Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.

Proficient in Microsoft Word, Excel, PowerPoint. Access database proficiency a plus.

Knowledge of eCTD publishing systems (ie. Lorenz Docubridge), EDMS technology and related publishing tools.

Working knowledge of US FDA (OGD/CDER) e-submission requirements.

Knowledge/experience with CMC regulatory requirements.

Excellent verbal and written communication skills.

By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.



Contact: arawat@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now