ANKIT KUMAR RAI

Project Executed in Middle-East:

• Prepared eCTD and CTD dossiers for regulatory submissions in Saudi Arabia, Bahrain, Qatar, Kuwait, UAE, and Oman.
• Dossier Gap Analysis and Technical Document Review - (Pre-submission and Post-submission).
• Regulatory Query Evaluation, response compilation, and submission—(new submissions, renewals, and variations from agencies and partners from Middle Eastern markets).
• Change Control and Post-Approval Change Assessments (Quality & Administrative)
• Variation filings: (API, Drug Product, Excipients, API & DP Spec STP, MFG site, Vendor Additions, MAH change, Batch release site change, batch size change, Shelf-life extensions & reductions, and New ROS).
• Artwork Review and Finalization: New Submissions and Commercials.
• In-licensing project handling and filings in Middle Eastern markets.
• Regulatory filing status, track maintenance, and coordination with cross-function teams.
• Site Registration and Renewals.

Achievements:

Chairman's Annual Award: Extra miler of the Year

Product registrations: done in the UAE, Saudi Arabia, Bahrain, Kuwait, Qatar, and Oman.

Variation Approvals: (batch size, vendor addition, batch release site, specification and method, shelf-life extensions) in the UAE, Saudi Arabia, Qatar, Kuwait, Israel, Jordan, and Lebanon.

Site registrations: Successfully done in the UAE, Iraq, Saudi Arabia, Kuwait, and Qatar.

In-licensing projects: Executed in Saudi Arabia and the UAE markets.

• Responsible for the registration of medicinal products for human use in different markets, which include North and South America, Asia, and Africa.

Projects Executed in LATAM.

• Preparation and review of CTD and country-specific dossiers for various North and South American countries.
• Site registration, variations (shelf life, batch size, vendor, and ROA), and query handling from FDAs and customers.
• Renewal application filing and coordination with customers for the registration and variation.
• Quality data review, Gap Analysis, and dossier evaluations.
• Registration sample arrangements, and CPP applications.

Achievements:

Product registrations: Done in Mexico, Cuba, the Dominican Republic, Costa Rica, Jamaica, Colombia, Ecuador, Chile, Peru, Paraguay, Bolivia, El Salvador, and Panama.

Variation Approvals: Successfully done in DR, Costa Rica, Chile, Colombia, Peru, and Paraguay.

• Preparation and review of ACTD and CTD dossiers for the different dosage forms, i.e., tablets, capsules, dry powder suspensions, and dry powder injections.
• Regulatory query handling from the customers and FDAs.
• Experienced in the preparation of regulatory dossiers (ACTD) for ASEAN (Vietnam, Thailand, Philippines, Myanmar), and CTD for African countries (Tanzania, Kenya, Uganda).
• Preparation of quality summaries (QIS, QOS).
• Preparation of product labeling (SPC, PIL), and artwork review.
• Preparation of the Draft COPP and Quality Document Review.

• Professionally and strictly trained in GMP, GDP, data integrity activities, and batch packing processes.
• Experienced in handling Blister Packaging Machines, ElmackPack 3015, Autocartonator 100, Bulk Packaging Machine Pharmapack, and Strip Packing Machine, In-process checks and line clearance processes.