Apr 2024 – Dec 2025 · 1 yr 8 mos · Remote

Sep 2021 – Mar 2024 · 2 yrs 6 mos · Remote

Oct 2018 – Sep 2021 · 2 yrs 11 mos · Bengaluru, Karnataka, India

• Responsible for planning, coordination and execution- preparation. compilation and review of post approval life cycle management (Quality variations, renewal applications) of the marketing authorizations for Global market.
• Independently responsible for regulatory submission strategy, preparation, compilation, review & submission correct and complete data within the scope of regulatory compliance & dossier finalization for National, MRP, DCP & Centralized procedures. (Inhouse/In-licensing/Out Licensing)
• Performing RA Assessment and determining change classification and providing focused support to assist and prepare submission to support changes and product life cycle pertaining to all assigned deliverables.
• Review of the quality and analytical data as per the pharmacopoeia viz. Specification, Analytical methods, batch records, Stability, Finished product/Packaging material data for compilation of the dossier.
• Worked on work-sharing, grouping & super-grouping EU variations
• To liaise and make frequent interactions with competent HA to discuss and provide right answer/solutions to HA queries.
• Responsible end to end submission to respective through CESP/ Centralized EMA eSubmission gateway web portal.

Nov 2016 – Oct 2018 · 1 yr 11 mos · Mumbai Area, India

• Assist in preparation, coordination and timely implementation of regulatory activities in support of Module 3 and Module 1 Submissions and other operations and cross-functional activities for the selected products and marketed across Europe
• Preparation and review of pre-compiled eCTD Module 3 dossiers before final dispatch and submission.
• Experience with QMS Trackwise, Lorenz DocuBridge
• Responsible for the operations and management of regulatory activities pertaining to new medicinal products (New product development) from in-house or 3rd party sources and out licensing (OL) as well as those already registered (Product lifecycle management) in the countries of Middle East & Africa including GCC Market

Jul 2015 – Oct 2016 · 1 yr 3 mos · Mumbai, Maharashtra, India · On-site

Jun 2014 – Jul 2015 · 1 yr 1 mo · Mumbai Area, India

• Preparation, Compile and Processing regulatory Submission including Product Dossiers in CTD, ACTD, NeeS format as per the respective country’s guidelines for countries like Russia, Kazakhstan, Kyrgyzstan, Uzbekistan, Turkmenistan, Georgia, Mongolia, Armenia, Tajikistan, Belarus, Burkina Faso.
• Review of the quality and analytical data as per the pharmacopoeia viz. Specification, MOA, STP, batch records, Stability, Finished product/Packaging material data for the purpose of compilation of the dossier.
• Review of documents required for regulatory agencies (Viz. Analytical reports, process validation reports, Process validation Protocol, Pharmaceutical Development Reports, Protocols & stability data, Product characteristics (SmPC) and Patient Information Leaflet (PL).
• Answering the queries in coordination with team, as requested by the parties and Regulatory Agencies.
• Interact with various departments/ teams to collect documents required for regulatory compilation on time as per regulatory norms & able to review data received from plant.
• Coordinate with legal and logistics dept. for samples to be submitted to various importing countries.
• Frequent visits to plant to collect documents and for better understanding of production.
• Collection of data from the internet as per the requirement of the concerned countries for the new product development.
• Keep record & Update registration status of products for countries. Maintenance of correspondence files.

Oct 2013 – Jan 2014 · 3 mos · Nashik, Maharashtra, India

• Worked in Formulation and Development department of Glenmark Pharmaceutical Ltd, sinnar.
• Contributed to 3 most rated FnD projects.