Shraddha Mokal

Total experience of 10 years in pharmaceutical industry in which 5 years in Quality Control-Microbiology API and 5 years in Regulatory Affairs (API and formulation).

Dedicated Regulatory Affairs

Specialist with 4 years of specialized experience in global Drug Substance (Active Pharmaceutical Ingredient - API) submissions and 1 year in Post approvals. Proven track record of compiling, reviewing, and managing high-quality CTD Module 3 (3.2.S) dossiers for the US (FDA), Europe (EMA), Canada (Health Canada), and WHO (Geneva), Brazil. Expert in lifecycle management, responding to health authority queries, and aligning regulatory strategies with evolving global guidelines (ICH, FDA, EMA, Health Canada).

Regulatory Affairs Associate I – EU Post approvals - Tevapharm India Pvt Ltd. - Navi Mumbai

(2022-04 - 2023-01)

• Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
• Responsibility for MA compliance with both legislation and business needs.
• Prioritized, planned, and monitored regulatory submission pipelines while providing progress updates to stakeholders.
• Coordinated response documents to Health Authority questions within strict deadlines.
• Managed over 40 post-approval variations (Type IA, IB, II) for EU markets.
• Evaluated CMC change controls to guarantee high technical accuracy and strict regulatory alignment.
• Ensure approvals are secured within the stipulated timelines for designated projects.
• Compile answers to any deficiency questions from authorities.
• Tracked variation outcomes to keep internal registries accurate and up to date.
• Updated electronic databases and EDMS platforms including ADAM, GI, and RIM systems.
• Provided expert regulatory support to internal project teams and external stakeholders.
• Partnered with cross-functional teams across Teva Europe and European Regulatory Agencies.
• Delivered regular status updates to management regarding ongoing submissions and project risks.

Executive Regulatory affairs - Hemmo Pharmaceuticals Pvt. Ltd. - Navi Mumbai

(2018-09 - 2020-12)

Piramal Pharma solutions

• Led end-to-end compilation, review, and lifecycle management of Type II USDMFs (USFDA) and ASMFs/CEPs (EDQM) to drive international product approvals.
• Utilised PharmaReady software to seamlessly publish, validate, and submit regulatory dossiers in full compliance with eCTD standards.
• Spearheaded Marketing Authorization Application (MAA) submission strategies for internal and external clients across European National, DCP, MRP, and CEP pathways.
• Compiled data packages for WHO Prequalification of APIs.
• Compiled comprehensive data packages for the WHO-Geneva Prequalification of APIs, ensuring alignment with global health standards.
• Evaluated critical API manufacturing changes—including site transfers, process optimizations, and analytical method changes—to determine exact variation categories and mitigate compliance risks.
• Assessed site change controls to systematically identify, mitigate, and manage global regulatory impacts and compliance risks.
• Authored Technical Data Packages and Letters of Access (LOAs) for global regulatory authorities across US, Canadian, and European markets.
• Secured market access by successfully managing CDSCO approvals for new product WHO-GMP certifications and EU Written Confirmations.
• Coordinated with R&D, Production, QA, QC, and Business Development teams to streamline technical data collection and accelerate submission timelines.
• Maintained full lifecycle management of active DMFs by timely preparing and submitting annual updates, amendments, and master updates.

Sr. Executive Regulatory affairs - Exim Corporation - Lower Parel

(2017-06 - 2017-10)

• Review of technical documents such as BMR, specifications, batch analysis, Analytical validation data etc. received from suppliers and customers.
• Independent laboratory analysis and product evaluation (as per requirement) between supplier and customer.
• Preparation of COA, specification, TDS and MSDS on basis of Supplier and customer documents.

Jr. Officer Regulatory affairs - MEHTA API PVT LTD - Andheri

(2016-05 - 2017-06)

• Prepared and reviewed Drug Master Files (DMF) in compliance with current guidelines from global regulatory authorities.
• Managed eCTD submissions for Active Substance Master Files (ASMF) and Certificates of Suitability (CEP), including initial filings, revisions, and renewals for the European market.
• Authored Letters of Access (LOAs) for multiple global regulatory authorities, including Europe.
• Compiled electronic EDMF submissions ensuring full compliance with European Medicines Agency (EMA) standards.
• Successfully coordinated a Therapeutic Goods Administration (TGA) desktop audit for product registration in Australia.
• Led dossier renewals to maintain active product registrations in alignment with European Union (EU) regulatory requirements.
• Provided prompt technical support to resolve customer queries completely and maintain business continuity.
• Resolved deficiencies and queries raised by global regulatory agencies, including EMEA, Asia Pacific, and African authorities.
• Evaluated change controls to assess, document, and manage potential regulatory implications.
• Collaborated cross-functionally with Quality Control (QC), Quality Assurance (QA), and R&D departments to gather technical data for submissions.
• Reviewed critical documentation including analytical reports, process validation protocols/reports, pharmaceutical development reports, and stability data.

Sr. Officer microbiologist - M/S SHARON BIOMEDICINE LTD - Taloja

(2010-07 - 2014-03)

• Successfully faced rigorous regulatory audits from international health authorities including the UKMHRA, MFDS (Korean FDA), and WHO (Geneva)
• Conducted routine testing and method validation for raw materials and finished products
• Led environmental monitoring and area validation protocols for sterile production lines and Quality Control (QC) laboratories
• Executed water system validation and routine monitoring of Purified Water Generation and Distribution Systems using membrane filtration and pour plate techniques
• Authored, issued, and updated Standard Operating Procedures (SOPs) and work instructions to ensure constant audit readiness.
• Directed the technical design, initial setup, and periodic qualification/requalification of Microbiology Laboratories.
• Trained and mentored laboratory analysts, junior subordinates, and facility support staff on aseptic techniques and GLP protocols
• Overseen equipment qualification (IQ/OQ/PQ), routine calibration, and preventative maintenance for all lab instrumentation.
• Built and managed comprehensive microbiological databases to ensure data integrity and seamless retrieval.
• Managed and executed quality management systems (QMS), including the documentation of change controls and deviations.

Jr. Officer microbiologist - M/S INDOCO REMEDIES LTD. - PATALGANGA

(2007-09 - 2009-06)

• Microbiological analysis of Finished Product batches, Stability batches.
• Microbiological analysis of Raw & Purified water analysis & its documentation.
• Routine Microbiological Lab operation activities (preparation of media, culture maintenance, preparation of work dilution, incoming control of microbiological media and cultures, etc).
• Bioburden testing of equipment's used in API manufacturing.
• Microbiological monitoring of environment in production area which includes plate exposure/contact plate/ swab testing/air sampler.
• Preparation and review of standard operating procedures.
• Review of completed BMR, change controls, deviations and analytical work record and documentation such as issuance.

Microbiologist - Sumaraj Sea Foods Pvt. - Taloja

(2007-01 - 2007-09)

• Microbiological analysis of Product, Water and ice.
• Most probable Number test for water.
• Coliform count for water.
• Swab samples for personal protective equipments.
• Documentation

Post graduated diploma - Regulatory Affairs API - Institute of Pharmaceutical Management (2016 - 2016)

BSc - Microbiology - Mumbai University (2006-03 - 2006-03)

SSC & HSC - Mumbai University

Basic computer course - MS office, excel etc