Pharma Reddy
Dr. SUMEET JAIN
Regulatory Affairs
Ratlam
Summary
Accomplished Regulatory Affairs professional with over 17 years of experience in regulatory strategy, dossier submissions (CTD/ACTD/eCTD), and product lifecycle management across regulated and semi-regulated markets. Proven track record of handling international submissions, post-approval changes, and ensuring audit readiness. Strong leadership in mentoring teams, implementing regulatory systems, and maintaining compliance with global regulatory requirements (EU, USFDA, WHO, CIS, MENA, ASEAN, Australia, Taiwan, China, and other APAC markets). Seeking senior Regulatory Affairs position to drive compliance and business success.
Overview
4
4
Languages
18
18
years of professional experience
Work History
Senior Manager – Regulatory Affairs
Macleods Pharmaceuticals Ltd.
05.2024 - Current
- To plan and execute registration, re-registration, renewals, extension dossiers, and post-approval changes applications for export markets.
- Initiated requests, followed up, and coordinated with internal stakeholders (business development, QA, QC, R&D, technical services, production, packaging, account, purchase, and packaging development) for activities and documents related to technical dossiers.
- Adequacy, accuracy, and completeness check of technical documents (for example, CMC documents, clinical documents, other administrative documents of the technical dossier, open part drug master files, etc.). which are required during customer due diligence activities concerning the technical dossier, query response, renewals, and post-approval changes during product life cycle management.
- Adequacy, accuracy, and completeness check of technical documents (for example, CMC documents, clinical documents, other administrative documents of the technical dossier, open part drug master files, etc.). which are required during the customer due diligence, activities concerning the technical dossier, query response, renewals, and post-approval changes during product life cycle management.
- Provide regulatory support, including timely registration of new products and line extensions to support new product launches, tender applications, and whenever necessary.
- Initiation of request, follow-up, and coordination with internal stakeholders (business development, QA, QC, R&D, technical services department, production, packaging, accounts, purchasing, and packaging development cell) for the activities and documents related to technical dossiers.
- Facilitated regulatory support by registering new products and line extensions to ensure smooth product launches, and tender applications.
- Conducted reviews of CMC modules.
- Review of QMS, such as deviation, change control, out-of-specification, out-of-trend, and incident reports raised to provide regulatory assessment.
- Review of dissolution data required for filing.
- Support for new filing, other country-specific regulatory submission, as per the agreed business plan and readiness.
- To provide documents and other inputs to the corporate office for responding to regulatory deficiencies. Support for a timely response to deficiencies received from the agency for inputs from manufacturing.
- Led, mentored, and supported regulatory team professionals.
- Collaborated with regulatory bodies to maintain compliance and support successful product launches.
- Www.macleodspharma.com
Manager – Regulatory Affairs
ZIM Laboratories Ltd.
05.2023 - 05.2024
- Preparation of site registration documents and responses to their queries, and to ensure the respective site(s) are registered with the MOH according to their requirements for the export market. Management of the site registration database.
- Planning, review, and submission of the technical dossier, query responses, and due diligence responses in the respective CTD/ACTD/eCTD for export markets.
- Initiation of request, follow-up, and coordination with internal stakeholders (business development, QA, QC, R&D, technical services department, production, packaging, accounts, purchasing, and packaging development cell) for the activities and documents related to technical dossiers.
- To plan and execute registration, re-registration, renewals, extension dossiers, and post-approval changes applications for export markets.
- Adequacy, accuracy, and completeness check of technical documents (for example, CMC documents, clinical documents, other administrative documents of the technical dossier, open part drug master files, etc.). which are required during customer due diligence activities concerning the technical dossier, query response, renewals, and post-approval changes during product life cycle management.
- To ensure structural compliance with the BE synopsis and report in accordance with the approved protocol(s) and requisite guidelines.
- Follow up with R&D and QA for registration samples, working standards, impurity standards, and other requested ancillary items (such as HPLC columns, filters, etc.). and external stakeholders (for example, API manufacturer, etc.) This is required by the concerned department for lab analysis.
- Upkeeping and maintenance of the regulatory status report, inclusive of new registration, re-registration, renewals, and post-approval changes.
- Coordinate and ensure the availability of valid licenses required for new technical dossier, renewal, or re-registration of the registrations, inclusive of manufacturing license with product permission, free sale certificate, local GMP, WHO GMP, brand name license, and COPP related to the registration dossier.
- Coordination of on-site and desktop inspections with concerned stakeholders at the manufacturing site, the local representative of the concerned country, and the MOH authority, or others (if any).
- Participated in discussion forums with internal and external stakeholders to confirm compliance with regulatory requirements discussed during meetings.
- Delivered regulatory support through timely registrations of new products and line extensions to enable successful product launches and tender applications.
- Conducted a comprehensive review of CMC modules.
- Review of QMS, such as deviation, change control, out-of-specification, out-of-trend, and incident reports raised to provide regulatory assessment.
- Review of dissolution data required for filing.
- To ensure regulatory compliance during the manufacturing of drug products.
- Support for new product launches through manufacturing plan participation, and ensuring timely availability of feedback for a smooth launch of the product, with verification of regulatory compliance.
- Support for new filing, other country-specific regulatory submission, as per the agreed business plan and readiness.
- To provide documents and other inputs to the corporate office for responding to regulatory deficiencies. Support for a timely response to deficiencies received from the agency for inputs from manufacturing.
- Www.zimlab.in
- Developed and implemented strategic initiatives to improve product quality and compliance standards.
- Led cross-functional teams to enhance operational efficiency and streamline processes.
Assistant Manager – Regulatory Affairs
Baroque Pharmaceuticals Pvt. Ltd.
09.2021 - 01.2023
- Manage the preparation and submission of new product registrations, post-approval submissions, renewals, and follow up closely on queries and through approval.
- Created CMC modules – 2 and 3.
- Manage and coordinate product life cycle management.
- In time, submission of Health Authorities' query responses related to product license renewal.
- Ensure regulatory compliance with local regulatory requirements.
- Ownership is to deliver the high-quality dossier for submission, as per the market requirements.
- Provide regulatory support, including timely registration of new products and line extensions to support new product launches, tender applications, and whenever necessary.
- Facilitated regulatory support through the timely registration of new products, and line extensions for product launches and tender applications.
- Conducted reviews of CMC modules.
- Ensure adherence to timelines and quality set parameters.
- Review of CMC-related submission documents, raw materials, packaging materials, and finished product analytical documents (specification, STP, COAs) intended for regulatory filing.
- Responsible for reviewing CMC modules.
- Review of formulation, generation of ingredient list, and claims as per set standards.
- Review of the batch manufacturing record and batch packing record, intended for submission.
- Review of the stability protocol, stability data, and process validation protocol and reports required for submission.
- Review of station-wise ongoing stability study data required for filing.
- Review of dissolution data required for filing.
- Review of QMS, such as deviation, change control, out-of-specification, out-of-trend, and incident reports raised to provide regulatory assessment.
- To ensure regulatory compliance during the manufacturing of drug products.
- Support for new product launches through manufacturing plan participation, and ensuring timely availability of feedback for a smooth launch of the product, with verification of regulatory compliance.
- Support for new filing, other country-specific regulatory submission, as per the agreed business plan and readiness.
- To provide documents and other inputs to the corporate office for responding to regulatory deficiencies. Support for a timely response to deficiencies received from the agency for inputs from manufacturing.
- Working as part of the process reference team to improve the ways of working. Also, to update relevant guidelines and procedure documents.
- Www.baroquepharma.com
Specialist – Regulatory Affairs
iMED Global
08.2018 - 09.2021
- Managed preparation and submission of new product registrations, post-approval submissions, and renewals, ensuring timely follow-up on queries for successful approvals.
- Created CMC modules – 2 & 3.
- Acquired knowledge of regulatory filing requirements in EU and CIS regions.
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Delivered regulatory support through timely registration of new products and line extensions to enable product launches and tender applications.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Evaluated CMC modules.
- Execution of regulatory strategies (local and regional) in line with business plan.
- Completed regulatory activities for multiple products, ensuring compliance with regulatory obligations and alignment with business objectives.
- Ensure adherence to timelines and quality set parameters.
- Review of Formulation, generation of ingredient list and claims as per set standards.
- Www.imedglobal.com
Executive – Regulatory Affairs
Micro Labs
01.2016 - 08.2018
- Oversaw changes post-approval to ensure compliance with regulatory standards. (Evaluation, compilation, and submission) like AR for US, Type IA, IAIN, IB, II, for EU.
- Addressed queries regarding post-approval submissions and responses.
- Communicated approved post-approval changes to stakeholders for implementation.
- Review of CMC-related submission documents, raw materials, packaging materials, and finished product analytical documents (specification, STP, COAs) intended for regulatory filing.
- Review of the batch manufacturing record and batch packing record, intended for submission.
- Review of the stability protocol, stability data, and process validation protocol and reports required for submission.
- Review of station-wise ongoing stability study data required for filing.
- Review of dissolution data required for filing.
- Assessed quality management system reports to ensure adherence to regulatory standards. Like deviation, change control, out specification, out of trend, and incident reports raised to provide regulatory assessment.
- To ensure regulatory compliance during the manufacturing of drug products.
- Support for new product launches through manufacturing plan participation, and ensuring timely availability of feedback for a smooth launch of the product, with verification of regulatory compliance.
- Support for new filing, other country-specific regulatory submission, as per the agreed business plan and readiness.
- To provide documents and other inputs to the corporate office for responding to regulatory deficiencies. Support for a timely response to deficiencies received from the agency for inputs from manufacturing.
- Review of master specifications, STP’s, analysis report, and worksheets for raw materials, packaging materials, and finished products to meet pharmacopeial compliance.
- Conducted reviews of dissolution profile data (DPDM) for innovators and exhibit batches.
- Conducted reviews of analytical documents for finished products from commercial batches before dispatch.
- Review of the test procedure with respect to pharmacopeial compliance.
- Sharing of the approval package, license particulars for the plant, and helping in the effective implementation of the changes.
- Guaranteed regulatory compliance and GDP standards while reviewing documents.
- Acting as a regulatory subject matter expert through cross-functional collaboration with R&D, Project Management, the Commercial Team, and other relevant stakeholders to ensure regulatory compliance and timely submissions.
- Coordinating with different stakeholders, such as the R&D team, the Clinical team, the Manufacturing team, and various API vendors, for regulatory documents and requirements for the timely submission of the dossier.
- Provided strategic regulatory support and guidance to internal and external stakeholders throughout product development, filing, and pre- and post-approval activities.
- Ensure timely circulation of approval information to the stakeholders for launch, and to maintain continuous supplies.
- Post-approval changes evaluation, strategizing, and performing its impact analysis across all licenses.
- Review of formulation, generation of ingredient list, and claims as per set standards.
- Www.microlabsltd.com
Management Staff
Cipla Ltd.
08.2015 - 12.2015
- Management of project for Regulated Market (i.e., Europe, USA, WHO, Australia, New Zealand and South Africa Market) for smooth and in time submission.
- Processed and addressed queries from Authority of Global and International Markets regarding submitted dossier.
- To perform risk assessment with respect to new products and facilities.
- Managed project for regulated markets (Europe, USA, WHO, Australia, New Zealand, South Africa) to ensure timely and compliant submissions.
- Assessment of change controls for the life cycle maintenance of the product.
- Review and compilation of section of Module 2 and 3 of dossier for submission in Global and International markets.
- Reviewed and implemented technical agreements with contract manufacturing sites to ensure alignment with regulatory standards.
- Review of Technical agreement with contract manufacturing sites and implementation.
- Www.cipla.com
Scientist-II – Regulatory Affairs
Torrent Research Centre
08.2011 - 07.2015
- Manage the preparation and submission of new product registrations, post-approval submissions, renewals, and follow up closely on queries and through approval.
- Authored CMC modules 2 and 3.
- Manage and coordinate product life cycle management.
- On-time submission of Health Authorities' query responses related to product license renewal.
- Ensure regulatory compliance with local regulatory requirements.
- Created a high-quality dossier for submission based on market requirements.
- Working as part of the process reference team to improve the ways of working. Also, to update relevant guidelines and procedure documents.
- Provide regulatory support, including timely registration of new products and line extensions to support new product launches, tender applications, and whenever necessary.
- Executed regulatory strategies to ensure compliance with business plans and market needs.
- Conducted regulatory tasks for specific products to fulfill obligations, and support business goals.
- Ensure adherence to timelines and quality set parameters.
- Assessed formulations, created ingredient lists, and claims aligned with regulatory standards.
- Review of CMC-related submission documents, raw materials, packaging materials, and finished product analytical documents (specification, STP, COAs) intended for regulatory filing.
- Review of the batch manufacturing record and batch packing record, intended for submission.
- Review of the stability protocol, stability data, and process validation protocol and reports required for submission.
- Review of station-wise ongoing stability study data required for filing.
- Review of dissolution data required for filing.
- Assessed QMS documents, such as deviations and change controls, to ensure regulatory adherence.
- To ensure regulatory compliance during the manufacturing of drug products.
- Contributed to manufacturing plans for new product launches, and delivered timely feedback to ensure smooth product launches with verified regulatory compliance.
- Support for new filing, other country-specific regulatory submission, as per the agreed business plan and readiness.
- To provide documents and other inputs to the corporate office for responding to regulatory deficiencies. Support for a timely response to deficiencies received from the agency for inputs from manufacturing.
- Www.torrentpharma.com
Scientist-II – Formulation Development
Torrent Research Centre
02.2010 - 08.2011
- Planning and organizing day-to-day research activities, and resolving procedural problems as appropriate to the timely completion of research objectives.
- Setting up, operating, and maintaining a variety of laboratory and/or field research equipment, as specified by the requirements of the research study.
- Managed documentation of lab notebooks, to prepare development reports, technical analytical documents (TAD), and master manufacturing documents (MMD).
- Www.torrentpharma.com
Research Trainee – Formulation Development
IPCA Laboratories Limited
01.2009 - 02.2010
- Managing and arranging day-to-day research tasks, resolving procedural issues effectively to achieve research objectives on schedule.
- Setting up, operating, and maintaining a variety of laboratory and/or field research equipment, as specified by the requirements of the research study.
- Conducted literature reviews to support drug formulation research and development initiatives.
- Assisted in experimental design, contributing to the optimization of analytical methods.
- Managed documentation of lab notebooks, to prepare development reports, technical analytical documents (TAD), and master manufacturing documents (MMD).
- Www.ipcalabs.com
Education
Doctor of Philosophy - Pharmacy
Sunrise College of Pharmacy
Alwar01-2025
M.Pharm - Pharmaceutics
Vinayaka Mission’s College of Pharmacy
Salem01-2009
B. Pharm - undefined
B.R. Nahata College of Pharmacy
Mandsaur01-2006
Skills
Regulatory strategy
Regulatory compliance
Regulatory submissions
Regulatory Risk Assessment
Quality systems
Product Life Cycle Management
Stakeholder & Project Coordination
Cross-functional team coordination
Strategic planning
Change management
Team mentoring
Accomplishments
- Led the submission of over 80 CTD/eCTD dossiers annually for ASEAN, Australia, South Korea, China, EU, CIS, and MENA regions.
- Successfully transitioned the regulatory function from manual to eCTD-based system, reducing query response time by 25%.
- Facilitated WHO GMP and MOH inspections as Regulatory SPOC, resulting in zero critical observations.
- Mentored and developed a regulatory team of 5+ professionals, increasing team efficiency by 40%.
- Standardized post-approval change processes across multiple sites, improving compliance and reducing risk.
Software
DMS System
SAP
Lorenz eValidator
Track Wise
Interests
Exploring pharmaceutical regulatory trends, Traveling, Cricket Enthusiast
Declaration:
I declare that the given information in this curriculum vitae is true to the best of my knowledge and belief.
Timeline
Senior Manager – Regulatory Affairs
Macleods Pharmaceuticals Ltd.
05.2024 - Current
Manager – Regulatory Affairs
ZIM Laboratories Ltd.
05.2023 - 05.2024
Assistant Manager – Regulatory Affairs
Baroque Pharmaceuticals Pvt. Ltd.
09.2021 - 01.2023
Specialist – Regulatory Affairs
iMED Global
08.2018 - 09.2021
Executive – Regulatory Affairs
Micro Labs
01.2016 - 08.2018
Management Staff
Cipla Ltd.
08.2015 - 12.2015
Scientist-II – Regulatory Affairs
Torrent Research Centre
08.2011 - 07.2015
Scientist-II – Formulation Development
Torrent Research Centre
02.2010 - 08.2011
Research Trainee – Formulation Development
IPCA Laboratories Limited
01.2009 - 02.2010
B. Pharm - undefined
B.R. Nahata College of Pharmacy
M.Pharm - Pharmaceutics
Vinayaka Mission’s College of Pharmacy
Doctor of Philosophy - Pharmacy
Sunrise College of Pharmacy