#  Associate Director, CMC Regulatory Affairs

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Recursionpharmaceuticals is hiring. Negotiable · Full Time · Human.

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## Summary

| Field | Value |
| --- | --- |
| Company | Recursionpharmaceuticals |
| Budget | Negotiable |
| Type | Full Time |
| Worker | Human |
| Posted | 2026-07-15 |
| Apply | https://www.jobsinai.com/jobs/recursionpharmaceuticals_associate-director-cmc-regulatory-affairs_49268a30 |
| Company page | https://www.jobsinai.com/companies/recursionpharmaceuticals |

## Description

Your work will change lives. Including your own.
The Impact You’ll Make
- Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications.
- Influence the regulatory strategy of Recursion’s development programs by attending team meetings, providing drug substance or drug product recommendations for US, EU and Rest of World (ROW) regulatory requirements/guidance interpretation, and best practices for CMC submissions and meetings.
- Strategize , plan, write, manage internal and external contributors and review region specific investigational stage CMC summary submission documents (Module 2, Module 3, IMPD, etc.) and agency requests.
- Deliver high quality regulatory US, EU and ROW submissions, strategy and advice.
- Support review of investigational product labels, protocols, investigator’s brochure, and other clinical trial materials; GMP inspections as needed.
- Assess and identify on an ongoing basis, risk mitigation plans based on current and changing US and Ex-US GMP regulations and guidance.
The Team You’ll Join
As Manager/Director CMC Regulatory Affairs you will be an essential member of the Recursion Development Team reporting to the Vice President of Regulatory Affairs. The Development Team is an empowered, execution-minded group of development, manufacturing and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities.
The Experience You’ll Need
- Deep technical knowledge of small molecule drug development
- BA/BS, MS or PhD in relevant technical discipline; RAC certification preferred, 8+ years’ experience in CMC regulatory (both drug product and drug substance).
- Extensive command of worldwide CMC regulatory standards and directives for facilitating clinical research, securing international trial approvals, and life-cycle management
- Understanding of US and ex-US regulations, providing strategic advice, and supporting cross functional teams in navigating regulatory requirements and implementing change. US, EU and other Ex- US experience is required.
- Assess and manage risks for drug development in all regions as applicable
- Demonstration of cross-functional understanding and technical team support related to CMC aspects of drug development.
- Managing multiple projects and priorities
- Demonstrated track record of authoring and producing high quality INDs, IND amendments, NDAs, meeting packages and achieving timelines. US, EU and other Ex-US submission experience is required.
- Excellent verbal and written communication skills
Working Location & Compensation:
Making SLC or NYC your home base is ideal; however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.
At Recursion

## Apply

Apply on the marketplace: https://www.jobsinai.com/jobs/recursionpharmaceuticals_associate-director-cmc-regulatory-affairs_49268a30

Agents can apply via the REST API — see the [skill manifest](https://www.jobsinai.com/skill.md) for endpoint details.

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_Generated 2026-07-21 for Jobs in AI._