The Role:
Reporting to the Vice President, Global Regulatory Affairs, the Director of Regulatory Operations will lead global regulatory operations, managing the submission process for regulatory filings and ensuring compliance with regulatory requirements. This role will provide operational oversight and support in the preparation and implementation of the regulatory strategic and operational plans. The successful candidate will have a strong background in Regulatory Information Management (RIM) systems, specifically Veeva Vault, and extensive experience in filing INDs and NDAs.
Responsibilities:
• Provide regulatory operations expertise and leadership to cross functional teams supporting the pipeline.
• Lead the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, train colleagues and project teams.
• Oversee and manage all Regulatory Operations submissions, systems related projects and submission compliance.
• Oversee technical aspects for submissions (e.g., eCTD document formatting, eCTD application, and transmission to regulatory health authorities).
• Perform quality assurance of submission documents and published output to ensure compliance with global eCTD requirements.
• Manage all internal and external publishing staff.
• Plan, schedule, and coordinate submissions.
• Maintain regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.
• Oversee the maintenance and optimization of Veeva Vault RIM.
• Ensure the accuracy, integrity, and security of regulatory data within the Veeva Vault system.
• Provide training and support to team members on the use of Veeva Vault RIM.
• Build submission binders and content plans for future regulatory submissions
• Stay current with regulatory requirements and industry best practices.
• Implement and maintain regulatory policies and procedures to ensure compliance.
• Prepare and present regulatory reports, metrics, and dashboards.
Competencies Include:
• Strong written/oral communication skills.
• Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to foster effective relationships and collaboration, motivate others, influence without authority.
• Excellent attention to detail.
• Excellent organization, communication, and multi-tasking skills.
• Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team.
Qualifications:
• Bachelor’s Degree in relevant/scientific field or related experience.
• 10+ years of work experience in pharmaceutical/biotech regulatory affairs, with at least 8 years of Regulatory Operations experience
• IND/CTA and NDA/MAA filing experience.
• Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software
• Understanding of drug development and business processes.
• Knowledge and experience of eCTD submissions.
• Knowledge and experience with enterprise document management systems (eDMS), specifically Veeva RIM.
• Knowledge of FDA, EMA, and ICH guidelines.
• Understanding of regulations and guidelines for drug development for IND and NDA/BLA.
