CMC Technical Writer/ Regulatory Technical Writer Job at Tap Growth ai in Santa

CMC Technical Writer/ Regulatory Technical Writer We are hiring a CMC Technical Writer to support global regulatory filings by authoring high-quality technical content for Module 3 and responses to agency questions. This role focuses on CMC regulatory submissions and biologics development, with an emphasis on advancing documentation that aligns with regulatory standards for ATMPs. 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+ years), Master’s (5+ years), or PhD (3+ years) 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! #J-18808-Ljbffr