Global Regulatory CMC Lead – Radiopharma

Orano USA; Plano (TX); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Dental, Vision insurance

401(k) with company match

Life insurance and disability coverage

Generous PTO and holidays

Training and development opportunities

Job summary

Orano USA seeks an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for radiopharmaceuticals. You will prepare and manage CMC documentation and submissions for the US and EU, collaborating with CMC, Manufacturing, Quality, and R&D teams to ensure compliance and timely approvals.

The role requires a minimum of 8 years in Regulatory CMC, strong written and verbal communication, and experience with IND/CTA, DMF/ASMF, and eCTD processes.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree a plus.
• Minimum 8 years Regulatory CMC experience and/or CMC technical-writing in pharma/biotech including injectables.
• Experience preparing regulatory submissions (IND/CTA, NDA/MAA, DMF/ASMF) and interacting with health authorities.

Responsibilities

• Lead development and preparation of global US/EU CMC submission documents; author, review, consolidate; collaborate with CMC team and manufacturing sites.
• Develop robust global regulatory CMC strategies; identify risks and mitigation to enable submissions and approvals.
• Manage regulatory CMC agency interactions and meetings; ensure timely submissions and first-cycle approval.
• Coordinate publishing and submissions for CMC dossiers with Regulatory Operations vendor (eCTD).
• Contribute to internal process improvements for regulatory and CMC workflows.
• Stay current on CMC regulatory intelligence and guidelines.

Skills

Regulatory CMC

Regulatory writing

US/EU submissions

GMP experience

Cross-functional teamwork

Education

Bachelor’s degree in a scientific discipline

MS/PhD/PharmD preferred

Tools

Microsoft Office

eCTD publishing

Job description

Orano USA seeks an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for radiopharmaceuticals. You will prepare and manage CMC documentation and submissions for the US and EU, collaborating with CMC, Manufacturing, Quality, and R&D teams to ensure compliance and timely approvals.

The role requires a minimum of 8 years in Regulatory CMC, strong written and verbal communication, and experience with IND/CTA, DMF/ASMF, and eCTD processes.