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Job Title: Regulatory Submission Manager, VBU Regulatory Operations and Compliance
- The Submission Management role supports all operational activities pertaining to the preparation of documents as part of a Marketing Authorization (MA) Application. This includes maintaining updates to the MA Content Plan, including changes to scheduled deliverables and contributing functional areas.
- Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with agency requirements and company standards. Acts as direct liaison with Global Regulatory Affairs staff and contributing departments to facilitate effective management of submissions.
- Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance. Sets priorities within area of purview and ensures adequate workload balance through interactions with other team leads and management.
- The role is responsible for ensuring MA documents are submission-ready and meet internal and regulatory standards for electronic submissions, and that documents properly processed in VBU's Electronic Document Manage System (EDMS). This requires regular engagement with MA stakeholders, actively tracking progress of MA components, and supporting access to relevant systems. The role will conduct QC of submission-ready documents and participate in the QC of draft/final submission outputs for the MA. All activities will be carried our according to applicable regulatory guidelines as well as relevant VBU SOPs.
- Performs report-level publishing and submission-ready activities for MA in accordance with internal standards and regulatory requirements.
- Completion of accurate metadata in the EDMS
- Word Documents
- Adherence and application of Company styles and standards
- Use of Word functionality to auto-generate required document navigation (bookmarks, hyperlinks, Table of Contents, List of Tables/Figures/Appendices)
- Verification that file renders correctly to PDF
- PDF Documents
- Creation of bookmarks and hyperlinks
- For PDFs with bookmarks and hyperlinks already in the document, verification of the accuracy of bookmarks and hyperlinks
- Audit of bookmarks and hyperlinks using TRS/ISIToolbox
- Application of correct document properties
- Verification that PDF meets technical specifications as outlined in FDA's "Portable Document Format (PDF) Specifications" and Company's Electronic Format Standards for Submission Documents
- Conducts QC of MA submission documents to ensure submission-ready standards are met
- Maintains MA Content Plan including changes to timelines and stakeholders. Provides visibility to progress using reports and dashboards.
- Incorporates changes to binders/documents including document metadata, target dates, and creation/addition/deletion of binders/documents/placeholders
- Interfaces with MA stakeholders to ensure sufficient awareness and understanding of MA document requirements including eCTD principles and lifecycle management to enable valid submissions, and to ensure the creation of global submission-ready documents and effective management of those documents in the EDMS.
- Provides effective and timely system support.
- Participates in the QC of draft and final published MA submission output to ensure compliance to regulatory agency standards and requirements for electronic submissions.
- Interprets industry or health authority guidance related to submissions and communicates changes.
- Executes day-to-day activities for MA.
- Supports the planning and execution of MA project.
- Other responsibilities as assigned.
- Education and Experience:
- Bachelor's degree or higher in a relevant technical or scientific field is required.
- Minimum of 6 years of pharmaceutical industry, regulatory publishing/submissions management experience.
- Working knowledge of Agency regulations and industry standards pertaining to regulatory operations is essential.
- Demonstrated understanding of the drug development process is highly preferred.
- Experience working within Regulatory Operations environment. Preferred experience in publishing and submission management.
- Evidence of working with US and/or EU Regulatory Agencies supporting Regulatory Dossier review and approval processes. EU experience preferred.
- Excellent skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Accustomed to fast-paced, highly-regulated environment with the ability to work independently with minimal supervision.
- Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed.
- Proficient MS Office (Word, Excel, Outlook, PowerPoint). Proficiency in Adobe Acrobat and TRS/ISIToolBox highly preferred.
- Excellent organization skills and sound attention to detail.
- Must work well with others and within global teams.
- Understanding of drug development process and knowledgeable of IND and BLA/MAA and other global submission requirements.
- Fluent understanding of regulatory submission processes and requirements including eCTD principles and lifecycle management.
- Solid understanding of systems and electronic technologies used to support regulatory submissions and records management. Preferred application and use of electronic submission publishing tools and/or document management systems.
- Preferred understanding of clinical development and fluent with the phases, processes and techniques used within a clinical development environment.
- Understanding of and has applied/adhered to ICH guidelines within the working environment.
- Analytical and Problem-Solving Skills - ability to understand and identify issues and opportunities using appropriate information. Determines the causes of problems and proposes creative and achievable solutions
- Communication Skills - ability to express one's self clearly and concisely to customers over the phone or with others within team; documents issues and/or concerns concisely and comprehensively
- Politically astute - and a confident and respectful motivator
- Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
- Knowledge Sharing - ability to capture knowledge within the organization and suggest improvements to processes or new potential solutions
- Change Management - ability to identify and support implementation of change positively for the organization and demonstrates flexibility and the ability to accommodate change
- Teamwork - the ability to work well in a highly cross-functional team environment
- Leadership Skills - develops, uses and shares knowledge with colleagues. Ability to prioritize own work and operates with minimal supervision. Has the ability to lead and motivate team members, without direct line management responsibility
- Strategic Approach - identify, create and support implementation of processes for Document Management and Regulatory Submission Publishing that satisfy Company needs
- Requires less than 10% travel.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
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