MA

Moizuddin A.

Regulatory Affairs Manager at SIGA Technologies

Moizuddin A. has a strong background in regulatory affairs, with a focus on pharmaceutical companies.

Starting in 2014, Moizuddin worked as a Regulatory Affairs Associate at Baxalta, where they compiled BLA dossiers in eCTD format for FDA submission. They also collaborated with cross-functional teams to ensure consistency.

In the same year at Hospira, Moizuddin held the role of Regulatory Affairs Specialist, where they created and reviewed ANDA and Stability Protocols, developed quality documentation, and managed nonconformance paperwork.

In 2015, Moizuddin continued their work at Hospira as a Global Regulatory Affairs Associate, responsible for creating, reviewing, and approving ANDA and Stability Protocols, as well as writing work instructions and release SOPs.

Moving to Amgen in 2016, Moizuddin became a Senior Regulatory Affairs Associate. They were responsible for filling applications, coordinating licensing renewals, and handling government interactions. They also developed procedures for regulatory compliance and assisted the Regulatory Affairs team with regulatory filings and amendments.

In 2017, Moizuddin joined Curium Pharma as a Senior Regulatory Affairs Specialist, working on regulatory compliance for pharmaceutical products.

In 2018, Moizuddin joined Genentech as a Sr. Regulatory Affairs Associate, contributing to regulatory affairs initiatives.

Most recently, Moizuddin has been working at SIGA Technologies as a Regulatory Affairs Manager since December 2019.

Moizuddin A. pursued their Master's degree in Organic Chemistry from Osmania University, from the year 2000 to 2002. In addition, they also earned an MSC degree in Chemistry during the same period from the same institution.

Links

Previous companies

Amgen logo
Genentech logo
Baxalta logo
Merck logo

Timeline

  • Regulatory Affairs Manager

    December, 2019 - present

View in org chart