Santosh Rathod

About Santosh Rathod

Regulatory Affairs Professional with 7+ years of experience in the pharmaceutical industry. Throughout the experience, I have developed technical competences, regulatory policy knowledge and chemistry, manufacturing and controls (CMC) expertise. Brand safety updates for Health Canada involving Product Monograph, RLD, Artworks and Cartons update. Change Control Assessment and Variations preparation for product manufacturing in Canada and disturbed in the EU and International market. Compilation and submissions of Annual Report, Supplements (CBE-0 CBE-30 and PAS) for post approval maintenance activities for USFDA. Maintenance of regulatory compliance via Deficiency Response within due time. Working on eCTD with Veeva Vault for Submissions, Change Control Assessment, Labeling and Artwork update. I have diversified experience in various domains i.e. in USFDA, Health Canada, EU and International Market for CMC and Labeling. Also, I have developed my knowledge by learning the Post-approval changes to biological products regulated by the US FDA involve modifications to an approved application, such as a Biologics License Application (BLA), and require reporting to the FDA based on the potential impact of the change.These involves prior approval, supplements (CBE-30 or CBE-0), or annual reporting. I am confident in executing quality and deadline-driven work.

Experience

1. Regulatory Affairs Associate

   Teva Pharmaceuticals

   Aug 2017 — Present · Navi Mumbai, IN

Education

• Swami Ramanand Teerth Marathwada University

  Bachelor of Pharmacy

• Swami Ramanand Teerth Marathwada University

  Master of Pharmacology