POSITION: Regulatory Affairs Operations Specialist

This position is immediately available to join our Regulatory Affairs team. This role will be responsible for supporting the preparation, delivery, archiving, and tracking of  regulatory submissions and deliverables to FDA and other international regulatory bodies.

RESPONSIBILITIES:

• Plans and manages the operational aspects of submissions to regulatory agencies such as Investigational New Drug Applications (IND)/Clinical Trial Applications (CTA) and BLAs/Marketing Applications.
• Ensures the creation of compliant and high-quality regulatory submission packages
• Prepares the administrative section of filings and provides support to clinical/nonclinical sections 
• Responsible for QC and technical editing and document formatting for submission readiness (i.e., internal document hyperlinking, Tables of Contents, bookmarks, footnotes, appendices, etc.) prior to providing documents to the publishing vendor
• Provides assistance and expertise with regulatory authoring templates
• Takes responsibility for the secure archiving of all submissions to and from regulatory authorities and other regulatory essential documents.
• Keeps an up-to-date record/chronology of all correspondence with regulatory authorities.
• Tracks questions and commitments with regulatory agencies 
• Assists Regulatory management in the development of dossier plans and timelines consistent with regulatory requirements and the company’s regulatory strategy
• Assists with data entry in Clinicaltrials.gov. registrations and other registries
• Assists with the development of regulatory strategies by conducting research associated with regulatory precedence and intelligence and reviewing regulatory guidelines and regulations, as needed
• Assists with Target Product Profile and labeling development 
• Responsible for managing future software/systems implementation in the Regulatory Affairs Department (e.g., Electronic Document Management Systems, eCTD publishing and viewing software, etc.) 
• Interacts with internal regulatory or external departments such as R&D, Manufacturing, Quality Assurance, and Clinical/Medical Affairs staff to support the authoring and generation of eCTD compliant source documents and reports   
• Researches guidelines and regulations applicable to regulatory operations and applies knowledge in the preparation of compliant and approvable filings 
• Assist in updating department SOP’s based on relevant current regulations, regulatory guidance, filing requirements, and trends in the field
• Performs other such duties as may be assigned to you

REQUIREMENTS:

• Bachelor’s degree preferably in the life sciences or health-related field with a minimum of 3+ years of experience in regulatory submissions/operations and/or previous experience as Regulatory Specialist for clinical trials 
• High attention to detail and Expertise with MS Office, advanced PDF processing tools, and Regulatory Document templates  
• Knowledge of the content and organization of regulatory submissions, CTD, and eCTD structure 
• Experience with MS Project or other project management tools a plus 
• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  
• Ability to work as part of a team and independently; displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgement.
• Strong integrity and work ethic are critical.
• Ability to build relationship with co-workers and external vendors.
• Able to anticipate problems.