Pharmaceutical CMC Writer

🚨 We’re Hiring: Pharmaceutical CMC Writer
📍 Location: Paramus, New Jersey, United States (Remote flexibility available)
💼 Contract or Full-Time Opportunity
💰 Competitive pay based on experience
🤝 Client: Leading Global Pharmaceutical Company

We’re looking for a skilled CMC (Chemistry, Manufacturing, and Controls) Writer to join our client’s regulatory affairs team. This role involves authoring and reviewing critical regulatory documents for drug development and submissions to US-FDA and EU-EMA.

You’ll be contributing to:
✅ Writing and reviewing CMC sections for IND, NDA, BLA, MAA, and IMPD submissions
✅ Ensuring CTD/eCTD format compliance and alignment with FDA/EMA/ICH guidelines
✅ Collaborating with scientists, QA, regulatory, and manufacturing teams
✅ Drafting responses to regulatory authority queries (RTQ, AR, DSUR)
✅ Helping establish internal CMC submission processes and documentation templates

What we need from you:
🎓 Bachelor’s or higher in Chemistry, Pharma, or related field
🧠 Hands-on experience in regulatory/CMC writing
📂 Familiarity with global submission standards and eCTD format
📈 Project coordination skills are a plus!

💼 Apply Now or refer a friend!
📩 Send resume to: Shantanusinghrathore8@gmail.com
📣 Posted by Freelance Recruiter Shantanu | SnapX.ai