Regulatory Affairs
Contract Regulatory CMC Writer
Author Module 3 content for a radioligand therapy NDA. A six-month remote contract working closely with process development, analytical and regulatory CMC leads.
A typical mandate
The company is preparing an NDA for a radioligand therapy that pairs a targeting ligand with a therapeutic isotope. Short shelf life and isotope supply make the CMC story unusual. The regulatory CMC lead needs an experienced writer to carry the authoring load.
What the role owns
- Author drug substance and drug product sections of Module 3 from source reports
- Write the Quality Overall Summary in Module 2.3
- Coordinate reviews with process, analytical and quality subject matter experts
- Track and resolve reviewer comments against a fixed submission timeline
- Keep content consistent with eCTD structure and company style conventions
What great candidates bring
- Degree in chemistry, pharmaceutical sciences or a related discipline
- 8+ years of regulatory CMC writing, including Module 3 for an NDA or BLA
- Small molecule or radiopharmaceutical experience preferred
- Working knowledge of ICH M4Q, Q6A and Q8 through Q11
- Able to work independently with a short ramp-up
Why it matters
- Six-month contract with possible extension through submission
- Fully remote, with flexible hours
- Close working relationship with a seasoned regulatory CMC lead
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