Mikhail Tregub

Mikhail Tregub currently serves as the Regulatory Affairs CMC Manager at Acino, where he plays a pivotal role in ensuring the seamless registration and lifecycle management of pharmaceutical products across global markets. Leveraging over nine years of diverse experience in the pharmaceutical industry, Mikhail brings a comprehensive understanding of CMC (Chemistry, Manufacturing, and Controls) requirements, which is critical for successful product approvals and compliance. His expertise encompasses preparing and reviewing Module 2 and Module 3 documentation in eCTD format, enabling efficient submission processes for new drug applications, variations, and lifecycle updates.

At Acino, Mikhail is deeply involved in evaluating product changes, developing robust regulatory strategies, and ensuring adherence to Good Manufacturing Practice (GMP) standards. His background in manufacturing and process engineering, combined with his experience in R&D, allows him to effectively bridge technical and regulatory perspectives, facilitating clear communication between cross-functional teams. Mikhail’s role also involves close collaboration with global regulatory agencies, ensuring that all documentation aligns with current guidelines and regulatory expectations.

His skill set in GMP, validation, and quality assurance underpins his ability to manage complex regulatory dossiers and support product lifecycle management from development through commercialization. Mikhail’s proactive approach and meticulous attention to detail help streamline regulatory processes, reduce time-to-market, and maintain compliance across diverse markets. With his strong foundation in manufacturing, regulatory affairs, and quality systems, Mikhail continues to contribute significantly to Acino’s mission of delivering high-quality pharmaceutical solutions worldwide.