Senior Associate , Regulatory Operations CMC (1078648)

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.
  
  

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Contact: arawat@judge.com

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