SUMMARY OF POSITION
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 primary publisher of US Regulatory submissions.
The Senior Associate, Regulatory Operations reports into the 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.
QUALIFICATIONS • 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, 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.
We are an EEO Employer.