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Home Flexible Job Board Associate Director, Regulatory Operations and Intelligence

$175,400–206,400/yr 150d ago

Associate Director, Regulatory Operations and Intelligence

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Recursion Pharmaceuticals

NY

Full-time Permanent Remote

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Summary

The Associate Director will manage regulatory submissions and documentation, overseeing systems and gathering intelligence. Candidates must have a relevant degree and significant experience in regulatory affairs.

Job 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 $176,400 - $240,800 (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 decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better, and at scale — for patients who are waiting.

Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com, or connect on X 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.

Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

About the company

Recursion Pharmaceuticals

Recursion is a clinical stage TechBio company focused on radically improving lives through innovative technology.

Apply Now

About the company

Recursion Pharmaceuticals

Recursion is a clinical stage TechBio company focused on radically improving lives through innovative technology.

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