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Regulatory Operations and Submissions Manager

Remote, NY

Posted: 06/28/2024 Employment Type: Direct Hire Job Category: Regulatory Job Number: 3872

Job Description

The Regulatory Operations and Submissions Manager manages complex submission projects and related processes.  Working cross-functionally to maintain processes and procedures related to regulatory submissions, the individual will assist in oversight of the integrity of the regulatory information management (RIM) system.

Responsibilities:
  • Act as a key Regulatory Operations representative for cross-functional working teams for matters related to electronic document management and regulatory submissions.
  • Manage the development and maintenance of a submission content plan, which includes a detailed list of all submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC
  • Act as Business Administrator for the day-to-day administration of Veeva Vault RIM
  • Assist change control efforts for configuration change requests on lifecycles, workflows, security settings, objects, document types/subtypes, etc.
  • Manage changes to system dictionaries, controlled vocabulary lists, templates, submission package (binder) structures, picklist values, document classifications, and other incidental changes in the system.
  • Assist in development and maintenance of training program
  • Act as a point of contact for users who have questions on the system
  • Assist with internal and external audits and inspection readiness activities.
  • Provides support in on-boarding and training new staff and provide ongoing guidance for system and processes.
  • Leads and participates in the development of optimal business processes (internal guides/work instructions, SOPs, etc.) and practices within the department to ensure high levels of support and to achieve high quality submissions and cost efficiency.
  • Responsible for independently managing and executing own projects and escalates issues or needs for support/resources to management as needed
  • Performs various document management assignments, including file transfer, migration, storage, tracking, and archival of regulatory submission and other functional area documentation.
  • Manage/provide guidance and operational oversight to ensure timely, high quality regulatory submissions. Participates in the development and execution of project plans.
  • Independently manage outsourced e-Publishing Vendor
  • Develop and implement publishing standards and processes for cross-functional regulatory submissions
  • Establish standard and best practices for day-to-day operations related to the management of documents related to Regulatory Submissions Operations
  • Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory submissions and keeps abreast of changes to regulations/guidances
  • Has solid technical and analytical skills and is able to recommend changes to or troubleshoot systems
  • Gather metrics on specific tasks and technical aspects for management updates
  • May supervise other Regulatory Operations staff

Requirements/Qualifications:
  • Bachelor’s degree and 7+ years of experience working in biotech/pharmaceutical industry 
  • 6 years of experience working in a regulatory, quality or compliance function with at least 4 years of regulatory operations experience in biotech/pharma industry.
  • Experience required in publishing activities and pre-publishing activities as well as compilation of eCTD submissions.
  • Publishing both US and ex-US submissions.
  • Viewed internally as a technical expert in the field of Regulatory Operations
  • Possesses an advanced, thorough understanding of global regulatory agencies’ submission processes, ICH eCTD and regional specifications and information systems used in regulatory publishing/submissions activities
  • Experience with Veeva Vault RIM
  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and eCTD publishing tools required.
  • Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail including proofreading required.
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion.
  • Experience developing business processes, Standard Operation Procedures, and Work Instructions preferred
  • Experience developing and giving trainings and guidance to various functions preferred.
  • Ability to work in a cross-functional team environment with changing timelines and priorities required.
  • Familiarity with competitive intelligence, regulatory standards, and information governance skills preferred.
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