Tap Growth ai is hiring: CMC Technical Writer/ Regulatory Technical Writer in Sa

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!