
Nazneen Naimuddin Khan Haji Khan
MS Regulatory Affairs ’26
Manufacturing Compliance Co-op at WAVE Life Sciences
What challenge did you tackle during your co-op?
The challenge of this co-op centered around ensuring manufacturing compliance and regulatory adherence at Wave Life Sciences, a biotechnology company focused on developing breakthrough RNA medicines. The organization needed to maintain strict regulatory standards while scaling their manufacturing operations for clinical trials and product development. This involved ensuring that both products and manufacturing processes complied with stringent regulatory requirements while supporting the team in navigating the complex intersection of pharmaceutical manufacturing, quality control, and regulatory frameworks in an innovative RNA therapeutics environment.
How did you approach solving this complex organizational challenge?
My approach focused on proactive compliance management—I didn’t just react to issues but worked to prevent them by understanding regulatory requirements deeply and translating them into practical manufacturing workflows. I collaborated closely with cross-functional teams to bridge the gap between scientific innovation and regulatory requirements, ensuring that as Wave Life Sciences developed cutting-edge RNA therapeutics, every step met the necessary compliance standards. I made sure that compliance wasn’t seen as a barrier to innovation but as an integral part of quality product development.
What skills did you develop and apply during this experience?
- Process validation and compliance verification methodologies
- RNA therapeutics development and production requirements
- Translating regulatory requirements into operational practices
- Adaptability in fast-paced biotech manufacturing settings
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