Recursion logo
Recursion

Decoding Biology to Radically Improve Lives

Director, CMC Regulatory Affairs

ComplianceComplianceFull TimeRemoteLeadTeam 201-500Since 2013H1B SponsorCompany SiteLinkedIn

Location

Worldwide

Posted

1 day ago

Salary

£111.1K - £141.8K / year

Seniority

Lead

No structured requirement data.

Job Description

Director, CMC Regulatory Affairs

Recursion

Role Description Your work will change lives. Including your own. - 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. Qualifications - 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. Requirements - This role is remote-friendly, with most work conducted from home. There may be occasional opportunities or expectations for travel to our Salt Lake City headquarters or other office locations. - At Recursion, we believe that every employee should be compensated fairly. Based on the skills, experience, and qualifications needed for this role, the estimated annual base salary range is: £111,100—£141,800. - In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package. Benefits - Annual bonus. - Equity compensation. - Comprehensive benefits package. Values - 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. - We learn actively and adapt rapidly. - We move with urgency because patients are waiting. - We take ownership and accountability. - We are One Recursion.

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