Neha Thete, MSRA, B.Pharm

Experience

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  Elder

  May 2014 - Jun 2014

  Trainee Intern

  1. Analyzed manufacturing process of Tablet, Capsule, and Ointment; developed technical reports and devised a streamlined manufacturing strategy which reduced costs by 20%. 2. Tracked inventory in Raw Material & Packaging Material Stores; ensuring on-time deliveries which increased distribution efficiency and billing accuracy by 18.7 %. 3. Assisted in analytical method development for API by HPLC (Shimadzu LC-20A); successfully reduced peak tailing by 10%.4. Executed Quality Control (QC) tests for API; proficiently documented data and maintained records in an electronic lab notebook. Show less

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  Spiro Lifecare Pvt. Ltd.

  Nov 2015 - Jun 2016

  Regulatory Operations Intern

  1. Compiled & authored marketing applications (CTD/ASEAN-CTD) format for 10 prescription generic drugs for submission to HAs of Tanzania, Australia, Ecuador, Hong Kong, Myanmar, and Malaysia. 2. Negotiated with clients efficiently; developed documents for Module 1 viz. SmPC, COA, FSC, thereby improving client satisfaction rate by 25%.3. Modified SOPs for regulatory compliance.4. Designed and implemented a document management & tracking system for global regulatory requirements; reduced lead time for dossier preparation from 6-7 days to 4.5 days.5. Collaborated with graphic designers, production team, and regulatory team for developing product labeling & packaging artwork. Show less

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  Lilu, Inc

  Jan 2018 - Jun 2018

  1. Devised submission strategies for a novel maternity device for international markets viz. EU (CE marking), Japan (Todokede/Self-declaration) & Korea (PMN), developing a roadmap towards the achievement of $45M+ in sales.2. Researched the $1.2B maternal aid products market; identifying the key market segment through sample online surveys and developed marketing strategy, performing SWOT and 5C analysis.3. Detailed business strategies for appointing a Designated Marketing Authorization Holder (DMAH), developing different business models for controlling product registration in EU, Japan & Korea.4. Analyzed impact of recent EU Medical Device Regulations changes on regulatory operations and functions, reducing chances of market failure by 40% by devising a change control strategy. Show less 1. Devised a registration strategy for regulatory approval of a novel Class I device, formulating a De Novo process action plan for release in the US market, interpreting potential obstacles & proposed mitigation. 2. Strategized filing requirements including registration documentation package, labeling & tracked device listing & establishment registration requirements thereby leading to overall savings of 10k+ in consultation fees.3. Developed & monitored submission timeline, assessing potential risks & developed submission tracker. Show less

  • Regulatory Affairs Capstone Project

    Apr 2018 - Jun 2018

  • Regulatory Affairs Experiential Project

    Jan 2018 - Mar 2018
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  L'Oréal

  Jan 2019 - Feb 2019

  Intern

  1. Formulated dossier for registration of different cosmetic products of L’Oréal brands such as Ralph Lauren, Maybelline, Nyx, Giorgio Armani, Yves Saint Laurent, Kerastase, Kiehl’s in India.2. Updated and proofread artworks of cosmetic products as per the CDSCO guidelines.

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  Roche

  Mar 2019 - May 2023

  Regulatory Affairs Executive

  1. Filed New Drug Applications, Line extensions, Global Clinical Trial Applications, Local Phase IV studies for novel molecules in India. Lead the defense of indication withdrawals of Tecentriq mUC & mTNBC resulting in first time retention of indications by the CDSCO in India after its withdrawal in a major country (i.e. US). 2. Provided regulatory support to tender team in acquiring crucial high amount tenders. Co-ordinated with State FDA Officers for obtaining tender-related certificates.3. Life cycle maintenance- fresh & renewal of RCs, ILs, revision of local package inserts, submission of DHPCs, post approval committments.4. Acted as a compliance coordinator ensuring timely tracking and submissions of regulatory compliance related activities such as DHPC, PI, HA commitments, CAPA planning including performing root cause analysis for deviation.5. Experience in facing global audits leading to no major safety findings.6. Represented Roche at OPPI (Import & Registration) meetings.7. Trained new hires, interns, business partners thus ensuring Affiliate compliance.8. Conducted SEC trend analysis and regulatory intelligence for assigned portfolio. Show less

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  Pfizer

  Jun 2023 - now

  Assistant Manager- Regulatory Affairs