Associate Director, Regulatory Operations and Intelligence

Role Summary

Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. This role also involves managing regulatory submission and publishing systems used in Regulatory Affairs.

Responsibilities

• Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary.
• Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing.
• Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies.
• Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. The interactive on-going trackers should be updated regularly.
• Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.)
• Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution.
• Stay updated on local and global regulatory submission requirements and implement new publishing requirements.
• Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents.

Qualifications

• Master‚Äôs or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
• 7+ years of industry-related experience in a regulatory publishing function.
• 5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo).
• Experience with setting up regulatory intelligence functions and tools is a must.
• Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus.
• Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers.
• Experience interacting with health authorities for operational systems is preferred.
• Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus.
• Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust.
• Critical thinker with excellent attention to detail.
• Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
• Experience in project management is a plus.

Education

• Master‚Äôs or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.

Additional Requirements

• Working Location & Compensation: This is an office-based, hybrid role in Salt Lake City / New York City office. Employees are expected to work in the office at least 50% of the time.