Sujitkumar Firke

About Sujitkumar Firke

Profile Snapshot: A high-end Regulatory professional having 20 years of experience in pharmaceutical industry presently associated with First Time US Pharmaceuticals as AGM - Regulatory Affairs. Competent with effective leadership that leads to high quality regulatory strategies, documentation and presentations meets standard timeline and achieve approval on the submissions. Dosage Forms Handling: Solid Orals (Conventional, Modified and Controlled), Topical and Transdermal Products, OTC products Submission Type Handling: ANDA, PAS, CBE, Annual Reports, PV, Deficiencies. eCTD Software handling: PharmaReady by Navitas (formerly Take Solution), Pragmatic SPL. Key Skills: Regulatory Affairs activities, OTC product launch, Regulatory Intelligence, Strategic Planning, Change Management, Data Integrity. Major Accomplishments: •Received Compliment on a very nice ANDA from Ms. Shannon Hill (Sr. Supervisory Regulatory, US FDA). •Played a vital role in submission of various ANDAs. •Received complete approval for various products and successfully commercialized in US. •Faced two US FDA audit successfully. •Successfully implemented serialization for commercial batches.

Experience

1. Agm-regulatory Affairs

   First Time Us Generics

   Jan 2023 — Present · Navi Mumbai, IN

Education

• I.P.E.R. Pune

  Diploma in Pharmaceutical Marketing Management

  2003 — 2003

• North Maharashtra University

  B. Pharm

  1998 — 2003

• IPM

  Diploma

  2008 — 2009