RHO

  • Director, Regulatory Operations

    Job Location US-NC-Durham
    ID
    2019-1442
    Type
    Regular Full-Time
  • Overview

    The Director of Regulatory Operations oversees the technical preparation, submission, and archiving of all regulatory submissions prepared by Rho on behalf of Rho’s clients, and ensures that all submissions to regulatory authorities are produced on time per project timelines and comply with regulatory authority requirements. The Director plays a critical leadership role with oversight of Rho’s publishing and operations personnel, capabilities, systems, and processes, to effectively publish and submit timely, high-quality, compliant regulatory submissions.

    Responsibilities

    • Responsible for Rho’s service offerings to clients for electronic submissions to FDA, Health Canada, EMA, and other international regulatory authorities.
    • Provide full representation for Regulatory Operations in project teams to support submission planning.
    • Collaborate with teams to plan, create and submit marketing applications (NDA/BLA, NDS, MAA, JNDA, PMA, 510(k), etc), clinical trial applications (IND, CTA/CTX, CTE, etc), and associated amendments, supplements, and variations, in electronic or paper formats.
    • Manage regulatory operations personnel and systems to ensure submissions are prepared in compliance with regulatory agency requirements and guidelines.
    • Maintain current knowledge of FDA, Health Canada, EMA, and ICH requirements for regulatory submissions, and ensures that all regulatory submissions comply with those requirements.
    • Routinely analyze updated submission requirements from regulatory authorities, assess impact on Rho’s publishing and submissions tools/processes, and implement changes and appropriate training if needed.
    • Serve as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory operations staff and representatives from cross-functional teams.
    • Conduct budgeting and forecasting for Regulatory Operations activities and deliverables for proposals to clients as well as internal project tracking.
    • Working with project teams, develop regulatory submission plans for all submissions, using appropriate project management tools and techniques, to ensure proper tracking of all regulatory submission deliverables.
    • Identify potential risks to submission plans and propose risk mitigation strategies.
    • Provide recommendations on resource needs for regulatory operations activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor).
    • Serve as system owner for regulatory publishing tools and systems (eg, eCTD publishing tools, electronic document management system (EDMS), library system, and electronic templates), and ensure that regulatory publishing tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations.

    Qualifications

    • Bachelor’s degree in a life science or related field
    • At least 10 years of regulatory operations experience in the CRO, Biotechnology or Pharmaceutical industries
    • Proven leadership, submissions project management, and organizational skills and experience
    • Strong interpersonal skills, oral and written communication skills, and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external customer groups
    • Creative thinker, motivational leader, strong manager
    • Ability to prioritize, delegate appropriately, and work under pressure in adhering to deadlines
    • Detailed knowledge of and extensive experience using eCTD publishing systems, EDMS technology, and publishing software (experience with Lorenz DocuBridge a plus)
    • Advanced proficiency using Microsoft Word, Microsoft SharePoint, Adobe Acrobat Professional, eCTD content templates, and experience with Microsoft Excel, Microsoft PowerPoint, and Microsoft Project
    • Solid experience administering and maintaining Regulatory document authoring templates
    • Expert knowledge in CTD/eCTD structure and requirements and solid understanding of US and international submission requirements in global regions such as Canada, Europe, Asia Pacific and other regulatory authorities.
    • Expert knowledge of regulatory submissions including marketing applications (NDA/BLA, NDS, MAA, JNDA, PMA, 510(k), etc), clinical trial applications (IND, CTA/CTX, CTE, etc), and associated amendments, supplements, and variations.
    • Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications, and ability to monitor and react to evolving US and global authority guidelines & regulations in drugs, biologics, medical devices and combination products.
    • Ability to solve complex problems
    • Ability to travel as needed.

    EOE. Veterans/Disabled

     

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