CMC Technical Writer / Regulatory Technical Writer

🌟 We're Hiring : CMC Technical Writer! 🌟

Are you an experienced technical writer with a strong foundation in CMC regulatory submissions and biologics development? We’re looking for a CMC Technical Writer to support global regulatory filings by authoring high-quality technical content for Module 3 and responses to agency questions.

📍 Location : Santa Monica, United States

⏰ Work Mode : Work From Office

💼 Role : CMC Technical Writer

What You'll Do :

📄 Author and finalize Module 3 documents in collaboration with Regulatory CMC and subject matter experts

✍️ Draft and review responses to regulatory agency questions related to CMC content

🧪 Leverage expertise in analytical method development for vector and T-cell products

🧬 Contribute technical insights into extended characterization, comparability, and product specifications

🌍 Ensure alignment with ICH guidelines and global regulatory standards for advanced therapy medicinal products (ATMPs)

What We're Looking For :

✅ Bachelor’s (7+ yrs), Master’s (5+ yrs), or PhD (3+ yrs) in Biochemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry, or related field

✅ Proven experience with CMC regulatory submissions (Module 3)

✅ Excellent technical writing skills and attention to detail

✅ Strong understanding of biologics manufacturing, aseptic processing, and analytical development

✅ Experience with analytical and process development for biotechnology products; cell therapy experience is highly preferred

✅ Ability to communicate complex scientific information clearly and concisely for regulatory audiences

Ready to make an impact? 🚀 Apply now and let's grow together!