Amala Saju is a regulatory affairs professional experienced in Chemistry, Manufacturing, and Controls (CMC) across global pharmaceutical companies, including Pfizer, Novo Nordisk, and currently, Sanofi. Her expertise lies in CMC technical writing focused on pharmaceutical manufacturing processes, quality control, and product specifications to support global regulatory submissions and compliance. She has contributed to over 100 CMC packages across major markets, including the US, EU, Australia, New Zealand, and APAC.

At Sanofi, Amala serves as a Regulatory Strategist with responsibilities spanning CMC change management, regulatory intelligence, and dossier development. She validates and oversees topics of global regulatory relevance, ensuring compliance with evolving guidelines.

Amala holds a Master’s degree in Pharmaceutics and Drug Design from BITS Pilani. Her work reflects a strong commitment to regulatory excellence and continuous improvement in CMC documentation, contributing to the effective development and approval of safe, high-quality medicines.