TANVEE NIMAVAT
Ahmedabad
Summary
Regulatory affairs leader with proven track record at Joinhub Pharma LLP, achieving over 300 dossier submissions and securing 50+ product registrations. Expertise in global regulatory strategy and cross-functional collaboration to drive compliance and operational efficiency. Proficient in managing health authority interactions and fostering effective team dynamics to meet ambitious goals.
Overview
22
22
years of professional experience
Work History
Senior Manager (HOD-Regulatory Affairs)
Joinhub Pharma LLP
12.2023 - Current
- Expertise in regulatory frameworks across the EU, US, and a wide range of ROW (Rest of World) markets, including the Middle East, ASEAN, Asia, LATAM, Africa, and the Caribbean.
- Proficiency in product registration for all dosage forms, including Oral Solid Dosage (OSD), Semi-solids, Topical, Injectables, Large Volume Parenteral (LVP), and more.
- Skilled in comprehensive dossier review, submission management, and effectively handling Ministry of Health (MOH) queries and client interactions.
- Managed all regulatory activities throughout the product lifecycle, encompassing variations, renewals, labelling updates, and post-marketing surveillance.
- Experienced in clinical operations, including CRO selection, Bioequivalence (BE) study execution, and monitoring.
- Led regulatory audits, authored Standard Operating Procedures (SOPs), and ensured inspection readiness through meticulous gap assessments and internal training programs.
- Managed risk assessment, change control procedures, and utilized regulatory project management tools like MS Project and Track wise.
- Fostered strong collaboration with Quality Assurance (QA), Quality Control (QC), Manufacturing, and Legal teams to support regulatory planning, product launches, and ensure cross-functional compliance.
- Delivered 300+ regulatory dossier submissions in 2 years, securing 50+ product registrations across LATAM, ASEAN, and Middle East markets through strategic regulatory leadership and cross-functional execution.
- Successfully planned, led, and executed 4 Bioequivalence (BE) studies for ROW markets, ensuring full compliance with international clinical and regulatory guidelines, while optimizing study costs through effective coordination and management of CRO partners.
Manager - Regulatory Affairs
Caritas Pharma Pvt. Ltd
10.2022 - 11.2023
- Develop and execute regulatory strategies for LATAM markets, ensuring compliance with country-specific requirements including Mexico, Ecuador and other regional authorities.
- Manage preparation, review, and submission of CTD/eCTD dossiers for Oral Solid Dosage (OSD) products, including tablets, capsules, and modified-release formulations.
- Lead product registrations, renewals, variations, and lifecycle management activities across multiple LATAM countries.
- Ensure CMC regulatory compliance, including review of drug substance and drug product documentation, stability data, manufacturing changes, and site registrations in line with LATAM guidelines.
- Coordinate cross-functionally with R&D, QA, QC, Manufacturing, Supply Chain, and Clinical teams to support timely submissions and approvals.
- Act as the primary liaison for Health Authority interactions, managing deficiency letters, queries, responses, and follow-up communications with LATAM agencies.
- Support and participate in regulatory audits and inspections, including preparation for GMP inspections and dossier audits required by LATAM authorities.
- Manage local agents, CROs, consultants, and distributors, ensuring regulatory compliance, submission quality, adherence to timelines, and cost efficiency.
- Track and interpret LATAM regulatory updates and guideline changes, assess business impact, and implement required actions across ongoing and future submissions.
- Prepare regulatory timelines, submission trackers, and management reports to support decision-making and portfolio planning.
- Mentor junior regulatory staff and ensure adherence to regulatory best practices and SOPs.
- Directed LATAM regulatory strategy for 200+ OSD products across 10+ countries, delivering 50+ submissions and lifecycle activities across major markets including Mexico, Ecuador, Bolivia & Dominical Republic.
- Achieved 70%+ first-cycle approvals and reduced regulatory timelines by 20–30% through proactive authority engagement and strategic dossier planning.
- Delivered 15–25% cost efficiencies, ensured uninterrupted product supply, and led successful audits and inspections with zero critical observations.
Assistant Manager - Regulatory Affairs
Cadila Pharmaceuticals Ltd
12.2021 - 11.2022
- Led end-to-end ANDA strategy and execution, including compilation, review, and submission of ANDAs in eCTD format for oral solid and topical formulations in compliance with USFDA regulatory requirements.
- Provided strategic oversight of regulatory lifecycle management, including interim and final review of CTD Modules (1–5), Quality Overall Summary (QOS), amendments, supplements, and annual reports.
- Acted as primary regulatory interface for the USFDA, managing deficiency letters (IRs/CRLs), coordinating cross-functional responses, and ensuring timely and high-quality submissions.
- Directed post-approval regulatory activities, including Annual Reports, PAS, CBE-0/CBE-30 filings, and PADER submissions, ensuring continued compliance and uninterrupted product supply.
- Oversaw technology transfer and regulatory knowledge transfer to manufacturing and site stakeholders, ensuring alignment between approved dossiers and commercial manufacturing processes.
- Established and maintained regulatory governance, SOPs, and compliance frameworks to support inspection readiness and audit success.
- Mentored and led regulatory teams, providing technical guidance and ensuring adherence to regulatory standards and timelines.
- Led and completed Adapalene Gel ANDA submission in just 2 months, significantly accelerating regulatory timelines while ensuring full USFDA compliance and dossier quality.
Executive - Regulatory Affairs
Torrent Research Centre
11.2014 - 12.2021
- Prepared and reviewed CTD/eCTD dossiers for US, EU, and ROW markets, supporting ANDA, MAA, and country-specific registrations for oral solid and topical products.
- Compiled CMC documentation (API, drug product, manufacturing, stability, validations) and supported Module 1–5 and QOS preparation.
- Coordinated cross-functionally with R&D, QA, QC, Manufacturing, and Analytical teams to finalize submission-ready dossiers.
- Supported lifecycle activities including amendments, variations, renewals, annual reports, and health authority query responses.
- Performed eCTD publishing, quality checks, formatting, and sequence management to ensure submission readiness.
- Independently executed the ANDA submission for Dapsone Gel amid COVID disruptions, securing USFDA approval in a rapid 9-month timeframe, demonstrating regulatory agility and ownership, despite operational constraints and remote coordination.
- Supported 50+ regulatory dossier submissions, including ANDAs.
- Enabled on-time, compliant submissions through high-quality CMC documentation, eCTD publishing, and cross-functional coordination, supporting smooth regulatory reviews and approvals.
Executive - Clinical Quality Control
Torrent Research Centre
04.2010 - 11.2014
- Provided quality oversight of clinical studies to ensure compliance with ICH-GCP, regulatory guidelines, SOPs, and protocols.
- Reviewed and approved clinical documents (protocols, ICFs, CRFs, IBs, monitoring plans, CSRs) ensuring data integrity and lifecycle compliance.
- Supported site qualification, initiation, and close-out activities through documentation and compliance review.
- Coordinated with Clinical Operations, Medical, Biostatistics, Data Management, and Regulatory Affairs to resolve quality issues and ensure inspection readiness.
- Participated in clinical audits and inspections, managing deviations, CAPAs, and audit observations to timely closure.
- Played a key role as representative of the Head – Clinical Quality Control in successfully clearing 2 ANVISA audits and 2 USFDA audits, supporting inspection readiness, audit coordination, and timely closure of observations.
Technical Assistant – Clinical Research
Torrent Research Centre
03.2005 - 03.2010
- Supported Bioequivalence (BE) studies through preparation of BENOC and Test License applications on SUGAM Portal.
- Assisted in clinical protocol preparation and reviewed key study documents (protocols, ICFs, CRFs, IBs) for accuracy and compliance.
- Supported Ethics Committee (EC) submissions and follow-up activities.
- Compiled and maintained SMF and TMF in line with ICH-GCP, ensuring inspection readiness.
- Coordinated with Clinical Operations, QA and study sites to collect, reconcile, and track study documentation.
- Maintained regulatory trackers and timelines and supported audits and inspections through complete and traceable documentation.
Quality Control Analyst
Posy Pharmaceuticals Pvt. Ltd.
06.2004 - 12.2004
- Performed laboratory analysis of raw materials, intermediates, and finished products as per approved specifications and analytical methods.
- Supported R&D of new chemical salts, including experimental studies and analytical evaluation.
- Conducted wet chemical and instrumental analysis, including operation of rotary evaporator and Karl Fischer titrator.
- Performed Water Content, assay, and purity testing and supported method development and validation activities.
- Ensured GLP-compliant documentation, data integrity, and adherence to SOPs, safety, and quality systems.
- Successfully developed stable chemical salts through laboratory experimentation, including Sodium Edetate, Sodium Bicarbonate (NaHCO₃), and Potassium Edetate, supporting product stability and downstream formulation requirements.
Education
M. Pharm - Pharmaceutical QA
KB RAVAL COLLEGE OF PHARMACY
GUJARAT08-2020
MBA - Operation Management
INDIRA GANDHI OPEN UNIVERSITY
GUJARAT03-2009
B.Pharm -
L.M. College of Pharmacy
Gujarat University06.2005
Skills
- Global regulatory strategy
- Oral solid dosage forms
- Topical product development
- Regulatory affairs leadership
- Product lifecycle management
- CTD/eCTD submissions
- Tablet and capsule formulation
- Modified-release formulations
- CMC regulatory strategy and documentation
- Post-approval activities
- Regulatory renewals and line extensions
- Cross-functional collaboration in R&D
- Quality assurance and control
- Manufacturing oversight
- CRO partnerships
- Health authority interactions
- Deficiency letter responses
- Regulatory queries management
- Dossier review and submission strategy
- Approval management processes
- Regulatory audits and inspections
- Inspection readiness planning
- Compliance management strategies
- Regulatory risk assessment and mitigation
- End-to-end regulatory support for development and commercialization
Languages
English
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1
Gujarati
Upper Intermediate (B2)
B2
Timeline
Senior Manager (HOD-Regulatory Affairs)
Joinhub Pharma LLP
12.2023 - Current
Manager - Regulatory Affairs
Caritas Pharma Pvt. Ltd
10.2022 - 11.2023
Assistant Manager - Regulatory Affairs
Cadila Pharmaceuticals Ltd
12.2021 - 11.2022
Executive - Regulatory Affairs
Torrent Research Centre
11.2014 - 12.2021
Executive - Clinical Quality Control
Torrent Research Centre
04.2010 - 11.2014
Technical Assistant – Clinical Research
Torrent Research Centre
03.2005 - 03.2010
Quality Control Analyst
Posy Pharmaceuticals Pvt. Ltd.
06.2004 - 12.2004
M. Pharm - Pharmaceutical QA
KB RAVAL COLLEGE OF PHARMACY
MBA - Operation Management
INDIRA GANDHI OPEN UNIVERSITY
B.Pharm -
L.M. College of Pharmacy