Category: Scientific & Clinical
Title: Associate Director, Regulatory Operations
Location: Pine Brook, NJ
Duration: 3+months temp to perm
- Publishes US Regulatory Submissions to the Food and Drug Administration: ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc.
- Works with 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.
- Develops and maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
- Manages all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
- Monitors and maintains familiarity with evolving and/or new regulatory e-submission requirements and ensures that all functional disciplines are apprised of the changes and trained accordingly.
- Authors, develops and/or collaborates on SOPs and Work Instructions for the Publishing and Electronic Document Management System.
- 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 a life science. Advanced degree preferred.
- Minimum of 7 years in the pharmaceutical industry with 5 of those years in regulatory affairs.
- Proficient in Microsoft Word, Excel, PowerPoint. Access database proficiency a plus.
- Advanced knowledge of eCTD publishing systems (DocuBridge), EDMS technology and related publishing tools (ISIToolBox).
- Excellent working knowledge of US FDA (OGD/CDER) e-submission requirements.
- Must be able to work independently and possess excellent decision- making and problem-solving skills.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.