Recursion Pharmaceuticals

Director, CMC Regulatory Affairs

New York, New York · Director

Sponsorship not specified$228k-$281kDetected 7 days ago

RESTBusiness DevelopmentRecruitingClinical TrialsClinical ResearchGMPFDA RegulatoryResearchLeadershipCommunicationCollaborationRegulatory Affairs

About the role

The Team You'll Join As Director CMC Regulatory Affairs, you will be an essential member of the Recursion Development Team, reporting to the Vice President of Regulatory Affairs.
There may be occasional opportunities or expectations for travel to our Salt Lake City headquarters or other office locations.
Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action. - We learn actively and adapt rapidly.

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.
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.
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 also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation.

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.
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.

Based on the skills, experience, and qualifications needed for this role, the estimated annual base salary range is:
New York City, Boston, & San Francisco Bay Area(s): $228,250-$280,720
Salt Lake City & all other U.S. locations: $207,500-$255,200
In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.

As 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
BA/BS, MS or PhD in relevant technical discipline; RAC certification preferred, 8+ years' experience in CMC regulatory (both drug product and drug substance).
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.
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:
This role is remote-friendly, with most work conducted from home.

This listing is sourced directly from Recursion Pharmaceuticals's careers page and normalized into a canonical job model.