Krupaliba Jadeja

About Krupaliba Jadeja

I am a skilled Pharma professional with expertise in Regulatory Affairs and Business continuity (Life Cycle Management) domain. My career highlights include: Product Life Cycle Management: I possess a strong track record of maintaining product life cycles for the US market, specializing in the filing of CBE0, CBE30, Prior Approval Supplements, Annual Reports, and PADER submissions. My in-depth knowledge of regulatory processes ensures that products remain compliant and up-to-date. eCTD Publishing Expertise: Proficient in independently managing eCTD Publishing activities, ensuring compliance with current regulatory guidelines to avoid any RTR queries. My capabilities encompass document preparation, page formatting, hyperlinking, PDF conversion, and quality control. I excel in creating an organized eCTD folder structure with proper file naming, insertion of documents, XML file creation, and metadata submission. Labeling Activities: I have a proven ability to independently handle labeling activities, including the review, finalization, and approval of product artworks viz. container labels, carton labels, and package inserts. Moreover, I have experience in SPL (Structured Product Labeling) preparation for both human prescription and OTC drug products. I am well-versed in submission requirements for establishment registration, renewal, GDUFA self-identification, and blanket no change certification. I am committed to ensuring regulatory compliance and excellence in document management throughout the product life cycle. My skills and expertise make me a valuable asset in the pharmaceutical and regulatory affairs field.

Experience

1. Regulatory Affairs Associate

   ISAZI

   Apr 2022 — Present · Ahmedabad, IN

   I am a seasoned Regulatory Affairs professional with expertise in key areas: Product Life Cycle Management: Skilled in CBE0, CBE30, Supplements, Reports, and PADER filings. eCTD Publishing: Ensures compliance through document management, XML creation, and metadata submission. Labeling: Manages container, carton, and SPL labeling activities, and registration requirements. My commitment to regulatory excellence makes me an asset in the pharmaceutical field.

Education

• Gujarat Technological University (GTU)

  M. Pharm

  2011 — 2013

• VEERAYATAN INSTITUTE OF PHARMACY, JAKHANIA 267

  B. Pharm

  2006 — 2010