Global Regulatory CMC Director - Radiopharma

Orano Med, LLC.; Plano (TX); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, and Vision insurance

401(k) with employer matching

Life insurance and Short- and Long-Dis

Paid Time Off and holidays

Training and Development opportunities

Job summary

Orano Med Theranostics in Plano, TX seeks an Associate Director, Regulatory Affairs - CMC to lead global regulatory CMC strategy for radiopharmaceuticals, oversee preparation of CMC dossiers for US and EU, and ensure timely, high-quality submissions in line with regulatory requirements.

You will collaborate with manufacturing, QA, and R&D, manage agency interactions, and drive continuous improvement of internal processes while staying current on CMC guidance.

Qualifications

• Minimum 8 years Regulatory CMC experience in pharma/biotech environments including injectables.
• Experience preparing regulatory submissions (IND/CTA, NDA/MAA, DMF/ASMF, briefing documents, responses).
• Technical knowledge in small molecules; radiopharmaceuticals knowledge is a plus.
• Experience with US/EU regulatory processes and interactions with health authorities.

Responsibilities

• Lead global US/EU CMC submission documents for radiopharmaceuticals; author, review and consolidate to deliver high-quality dossiers.
• Develop global regulatory CMC strategies; identify risks and propose mitigations.
• Manage regulatory CMC agency interactions and meetings.
• Coordinate publishing/submission for CMC dossiers (eCTD) with Regulatory Operations.
• Improve internal processes for regulatory/C M C workflows and stay current on CMC intelligence.

Skills

Regulatory CMC experience

Regulatory submissions

Health authorities interaction

GMP knowledge

Regulatory planning

Communication skills

Project management

Education

Bachelor's degree in scientific discipline

MS/PhD/PharmD preferred

Tools

Microsoft Office

Job description

Orano Med Theranostics in Plano, TX seeks an Associate Director, Regulatory Affairs - CMC to lead global regulatory CMC strategy for radiopharmaceuticals, oversee preparation of CMC dossiers for US and EU, and ensure timely, high-quality submissions in line with regulatory requirements.

You will collaborate with manufacturing, QA, and R&D, manage agency interactions, and drive continuous improvement of internal processes while staying current on CMC guidance.