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58618794 Senior Regulatory Operations Associate - Morristown, NJ

Job Information

ID :
# of Positions :
Minimum Education Level :
Bachelor's Degree
Experience Required :
Duration :
Full Time Regular
Shift :
Hours per week:

Job Description


This position is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. Serves system administrator for Alvogen's US Regulatory electronic document management system. He/she will serve as the primarypublisher of US Regulatory eCTD submissions.

The Senior Associate, Regulatory Operations reports into the Director / Senior Director, Regulatory Affairs and is based in Morristown, New Jersey.

Primary responsibilities of this role include the following:

Publishes US Regulatory Submissions to the Food and Drug Administration: ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc.
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 maintains familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensures 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 Document Management System.
Independently track and manage all correspondence between Alvogen and government agencies, including phone calls, emails, and relevant documents.
Accurately update and maintain spreadsheets and databases in a timely manner.
Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
Monitors and maintains the highest level of submission standards.
Performs other related duties as assigned.

Minimum of a Bachelor's Degree in science. Advanced degree preferred.
Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in the regulatory affairs operations role.

Job-Specific Competencies/Skills:

Proficient in Microsoft Word, Excel, PowerPoint. Access database proficiency a plus.
Knowledge of eCTD publishing systems, 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.
Highly motivated, results driven individual with unyielding predisposition to detail, accuracy and clarity.
Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
Must be able to work independently and possess excellent decision- making and problem-solving skills.
"An Equal Opportunity Employer, including disability/vets."


Company Information

Name :
Alvogen, Inc.
Description :
Alvogen is the next generation pharmaceuticals company. Our business model ensures competitive advantage through focused in-house capabilities and a network of partners for enhanced speed and flexibility. Alvogen currently has commercial operations in 35 countries around the globe, with regional hubs in North America, Romania and Taiwan.

Our passionate team is committed to continue to grow our business around the world and to becoming a top 5 global generic pharmaceuticals player. North America is our largest market with over 60 pending ANDA filings. Other markets include Romania, Hungary, Korea, Taiwan, Bulgaria, Japan, China and Russia.
Type :
Direct Employer
Address :
10 Bloomfield Avenue
Building B
Pine Brook, NJ 07058

Application Information

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