To maintain Clinical & Regulatory submissions to FDA for both pre and post marketed products (“Projects’).

Principal Responsibilities

• Manage the receipt, maintenance, approval, submission, and distribution of documents including nonclinical and clinical trial master files, adverse drug experiences, product complaints, regulatory submissions/correspondence, batch records and standard operating procedures;
• Control electronic templates for regulatory, professional affairs and clinical documents and SOPs;
• Initiate new SOPs, revise existing SOPs and manage SOP review process as required and as they relate to operations departments;
• Liaise with Professional Affairs and Regulatory departments to ensure compliance with regulatory reporting/submission deadlines;
• Coordinate publishing activities for all FDA submissions;
• Review advertising and promotional materials;
• Coordinate package insert and other labeling for SPL submission;
• Manage IND and NDA annual reports;
• Manage PDUFA and NDC activities;
• Other projects or duties, as assigned.

Requirements

• Required Must be able to handle several projects simultaneously, be detail oriented and extremely organized.
• Skilled in the use of word processing, spreadsheet, email, and database software.
• Experienced in drug development strategy.
• Experienced in eCTD submissions for INDs and NDAs.
• Education Bachelor’s degree or higher.
• Preferable Pharmaceutical industry experience with focus in regulatory knowledge and medical writing.