Regulatory Affairs Manager - Operations and Document Management

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Rockville, MD
$95,000 - $125,000
Job Type
Direct Hire
Jan 12, 2018
Job ID
Our client,  A well-established and growing Clinical Research Organization focusing on both Government and Private Sector Pharmaceutical Clinical Trials support and Data/ Statistics Clinical Coordination, has a new opening due to growth! The ideal location for this position is Rockville, MD, but there is an option to work from Frederick, Maryland or a northern Virginia office within the next few months.

We are hiring a Regulatory Affairs Manager for Operations and Document Management to create, oversee and direct all Regulatory Affairs Document Management activities for drugs, devices, and biologics (including vaccines) to ensure alignment and compliance with regional (country) and international (ICH) requirements for the registration, conduct, and reporting of studies involving human subjects. 

This is a unique role that will allow you to make your mark and create a Regulatory Documentation Organization including processes and procedures for current and future growth.

This includes applications to both initiate clinical studies and to bring therapeutics to market.  Provides counsel to the project team and manages the regulatory team, as appropriate, to meet company and project team goals.  Provides expertise in translating regulatory requirements into practical, workable plans.  Interacts with regulatory agencies, building relationships and rapport to facilitate the advancement of therapies through the regulatory processes.  Other project-based regulatory tasks, as assigned.
Provides corporate support, including drafting and maintaining Standard Operating Procedures (SOPs), preparing, reviewing and defending proposal submissions, teaching classes, supporting internal audit programs, and supporting other corporative initiatives, as assigned.  Selects, develops and evaluates personnel to ensure the efficient operation of the Regulatory Affairs function.

Regulatory Affairs Manager for Operations Support
The Regulatory Manager, Regulatory Operations Support is responsible for the overall oversight, management and operational activities for regulatory document management, including, but not limited to, controlled document management systems, electronic Trial Master Files (eTMF) and electronic submissions (e-submissions). 
Regulatory Managers providing Regulatory Operations Support role may have the following additional assignments:
  • Essential Document Management:
  • Develop, maintain, and oversee usage of standardized document descriptions for TMF components and other essential documents, including contract deliverables, generated during product development and clinical trial conduct, based on best practices and Emmes procedures and in conjunction with Subject Matter Experts
  • Develop, maintain, and oversee applicable SOPs (Project and Corporate) and templates to ensure that routine document management operations are performed in adherence with ICH/GCP/regulatory guidelines and best practices.
  • Establish and oversee document mapping from project team folders to archival systems, including the eTMF and other controlled electronic media, and establishing standardized document naming conventions.
    • Coordinate and oversee document management activities, including archiving, performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required.
  • Provide Corporate and project-specific eTMF (Veeva Vault) Support
    • Act as an administrator of the Veeva Vault eTMF system, setting up and maintaining the system in conjunction with the Clinical System Analyst team.
    • Establish and maintain company guidelines and work instructions for eTMF (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
    • Lead user training (internal and external) and train-the-trainer training sessions, establishing and maintaining user reference materials for all user types and tracking trained users, user access and eTMF permissions.
    • Track proposals and timelines for eTMF deployment, ensuring project resources are utilized appropriately given their site activation / close-out processes.
    • Oversee and support eTMF implementation at the corporate and project levels, establishing user roles and cross-functional governance to ensure optimal utilization.  Assist with optimal eTMF utilization and close out by assisting with the drafting and maintenance of paper to eTMF mapping documents responding to questions, advising on document placement, and trouble-shooting as needed.
    • Develop and maintain eTMF and TMF SOPs and templates according to the TMF reference model.
    • Ensure optimal use of eTMF functionality by analyzing project and industry best practices and transferring manual processes into automated workflows, as possible.
  • E-submissions
    • Act as liaison between publishing group and projects, educating teams and leading the process to ensure the receipt of publish-ready documents within established timeframes to meet anticipated submission deadlines.
    • Establish and implement processes for finalization and e-submission of documents to Regulatory Agencies, ensuring templates are correct and publishing is straightforward and costs are kept low.
    • Interact with publishing vendor to manage timelines, exchange documents securely and communicate document delivery dates
10% travel, local travel estimated.

Required Education and Experience
Regulatory Manager, Document Management Operations
  • PharmD or PhD in a scientific discipline, preferred along with at least 5 to 7 years of relevant experience in Regulatory Affairs and Document Management Operations.  BS/MS requires 8 to 10 years of relevant work experience in Regulatory Affairs or 10+ years of experience with a BS only. 
  • RAC Certification Preferred for Regulatory Strategy Role, relevant industry association (AIIM/CQA/CfPIE) certifications for Regulatory Operations Role.
  • Must have in-depth knowledge of U.S. FDA and International regulations, guidance documents, and regulatory process pertaining to drug development, clinical testing and approval, inclusive of CMC, clinical and non-clinical requirements / dossier content and presentation.
  • Experience in NIH-sponsored clinical programs a plus.
  • Experience in line-management and/or mentoring less experienced Regulatory Affairs staff
  • Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
  • Thorough understanding of electronic submissions for ICH/FDA compliance to electronic Common Technical Document (eCTD) standards.  With the ability to prepare the company to submit electronically, creating standard practices and working with private industry and government systems.
  • Working knowledge of GCP and TMF governing regulations, such as the TMF Reference Model
  • Thorough understanding of records management best practices and core requirements and in Drug Development
  • Experience with the evaluation, implementation and maintenance of electronic document management systems within the pharmaceutical company setting.
  • Experience evaluating and utilizing third party document sharing tools, such as LiveLink, FileNet, etc.
  • Excellent organizational, planning, analytical, and problem solving skills.  Attention to detail required
  • Sound knowledge in MS Office (Word, Excel, and PowerPoint) and PDF rendering tools.
  • Experience in the areas of Infectious Diseases, Cellular Therapies, Ophthalmology Medicine, Substance Use Disorders, and/or Child and Maternal Health is a plus.