Associate Director, Regulatory Operations and Intelligence - New York - RECURSION CO

    RECURSION CO
    RECURSION CO New York

    20 hours ago

    Description
    Your work will change lives. Including your own.
    The Impact You'll Make
    We are seeking an 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. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs.
    • 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.
    The Team You'll Join
    Reporting to the Vice President, Regulatory, you'll be an integral part of the regulatory team leading regulatory operations and intelligence function. On the diverse team, you'll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion's regulatory strategy along with leading the intelligence function to disseminate impact from regulatory changes across different regions.
    The Experience You'll Need
    • Master's 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.
    Working Location & Compensation:
    This is a fully remote opportunity in the United States. At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $175,400 - $206,400 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
    #LI-REMOTE
    #LI-DB1
    The Values We Hope You Share:
    • We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
    • We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
    • We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
    • We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
    • We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
    • We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
    Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
    More About Recursion
    Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
    Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at , or connect on X (formerly Twitter) and LinkedIn.
    Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
    Accommodations are available on request for candidates taking part in all aspects of the selection process.
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