Minu Kumari
Milton Keynes,Milton keynes
Summary
Regulatory specialist with 10 years of experience in managing national IRP and EMA submissions, including pre- and post-approval activities. Expertise in variation filings, regulatory strategy planning, and CMC documentation. Proven ability to respond effectively to health authority queries and support scientific advice meetings while ensuring compliance with MHRA and EMA guidelines.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Consultant
Mundipharma Research Limited
10.2024 - Current
- Create, update, and maintain Country Label Deviation documents for national products.
- Update, review, and support approval of local artworks in line with regulatory requirements.
- Delivered local regulatory intelligence and guidance to internal stakeholders, ensuring compliance with evolving regulations.
- Provide in-country regulatory support for product launches.
- Review, update and maintain local Regulatory SOPs to ensure compliance.
- Prepare and update national SmPC and PIL documents.
- Finalise national texts and manage national phase submissions for MRP/DCP procedures.
- Update national SmPC/PIL and additional Risk Minimisation Measures (aRMMs) to local compendia websites (e.g., eMC).
- Prepare and update local abbreviated Product Information (PI), including digital PI management for the UK via eMC.
- Served as operational liaison with local third parties, vendors, and key stakeholders to facilitate effective collaboration.
- Supported affiliate regulatory activities by informing local cross-functional teams of regulatory updates and changes, enhancing compliance readiness.
- Perform regulatory assessment reviews for:CMC variations
Labelling variations
Other regulatory variation types as required
- Prepare and submit national regulatory submissions (e.g., variations, responses to queries/RTQs) using Veeva Vault RIM, local documentation, and content plan completion (non-CESP submissions).
- Conduct CCDS compliance checks to ensure alignment with global reference documents.
- Coordinate fee payment requests and manage Proof of Payment (PoP) documentation.
- Prepare and manage national renewal submissions, including Veeva Vault RIM updates, local documentation, and content plan completion.
- Collaborated with team members to achieve target results.
- Managed complaints with calm, clear communication and problem-solving.
- Achieved service time and quality targets.
- Identified issues, analysed information and provided solutions to problems.
- Enhanced working relationships by participating in team-building activities.
- Demonstrated consistent hard work and dedication to achieve results and improve operations.
- Prepared and managed national PSUR submissions for products not included in the EURD list, including Veeva Vault RIM documentation and content plan completion.
- Prepare local documents for MRP/DCP variations, renewals and PSURs.
- Update regulatory systems including Veeva with submission details, approval dates and national phase decisions (MRP/DCP country decisions).
- Manage activities related to cessation of marketing, sunset clause monitoring and withdrawal of Marketing Authorisations.
- Review regulatory data to support quarterly Pharmacovigilance reporting (MA status, safety variations, etc.).
- Inform dependent/reliant markets and the Global Labelling Team regarding changes to reference market product information.
- Respond to Medical Information team queries related to regulatory topics.
- Submit and track educational materials (aRMMs) until approval and ensure communication to relevant cross-functional stakeholders.
- Manage and support Change Control requests for local regulatory changes.
- Act as the primary point of contact for Health Authorities for client-related queries.
- Review promotional and non-promotional materials to ensure regulatory compliance.
Regulatory Affairs Manager
Farmak Pharmaceuticals UK Ltd
Luton London, bedforshire
10.2020 - 09.2024
- Reviewed and submitted regulatory documents to MHRA and EMA, ensuring compliance with RMPs, PSURs, SPCs, PILs, and safety data requirements.
- Prepared and reviewed regulatory submission dossiers for new submissions to MHRA, including IRP and national method compliance.
- Provided CMC and regulatory support for approved products, including post-approval variations (Type IA and IB), product renewals, and submissions for growth markets.
- Collaborated cross-functionally to assess regulatory changes, identify risks and opportunities, and support strategic communication with project leads, enhancing project compliance.
- Built and sustained relationships with regulatory agencies and vendors, enhancing regulatory insight and fostering collaboration.
- Maintain and routinely review Regulatory Databases, ensuring country summaries are accurate, current, and updated promptly.
- Maintain the Regulatory tracker, like the Master product list, variation, and change control.
- Preparation and Review of Annual reports as per the MHRA Markets.
- Requested and prepare the regulatory change control impact on product quality and safety.
- Supported preparation of regulatory submissions and QA-related documentation.
- Prepared and submitted piggyback and change-of-ownership applications to MHRA and provided guidance on technology transfer.
- Training by TOPRA Sponsored: Navigating Global Market Authorization Submissions.
- Maintained and built good relationships with internal and external CMO, client, and Regulatory Authorities.
- Review and update the Regulatory SOP to ensure it complies with UK and EMA regulatory legislation and quality principal standard policies.
Regulatory Affairs Associate CMC
Sun Pharma ltd
10.2017 - 08.2020
- Compiled CMC (Module 3) sections for IND submissions, ensuring compliance with FDA requirements.
- Coordinated CMC data collection from internal teams, CMOs, and analytical laboratories to support timely submissions.
- Prepare and review specifications, analytical methods, and validation summaries for inclusion in the IND.
- Develop and write drug substance and drug product manufacturing process descriptions for IND dossiers.
- Identify CMC gaps and perform risk assessments to ensure IND readiness.
- Support responses to FDA questions, including information requests and amendments during IND review.
- Prepared stability protocols, stability reports, and shelf-life justifications for clinical trial materials, contributing to regulatory compliance.
- Ensure proper documentation of raw materials, excipients, packaging components, and control strategies.
- Review and support GMP compliance documentation, including batch records and manufacturing controls.
- Work closely with cross-functional teams (QA, Manufacturing, Analytical, Regulatory) to ensure timely IND submission and regulatory compliance.
Quality Assurance Trainee
Getwell Pharmaceutical Private Limited
01.2016 - 09.2017
- Prepared regulatory submissions and quality assurance documentation to support adherence to industry standards.
- Reviewed documentation, including batch records, deviation reports, and change controls, to ensure accuracy and compliance.
- Planned, scheduled, conducted, reported, and evaluated internal departmental audits to ensure compliance with regulations and standard operating procedures.
- Participated in FDA, WHO GMP, and NABL quality check audits on two occasions.
Education
Master of Pharmaceutical Sciences -
Manipal College of Pharmaceutical Sciences
India05-2016
Bachelor of Pharmacy (B. Pharm) -
Manipal University
India05-2014
Skills
- Veeva Vault certification
- LIMS database management
- Regulatory compliance
- Regulatory strategy
- Submission preparation
- CMC documentation
- Product lifecycle management
- Risk assessment
- Change management
- Problem-solving and analysis
- Cross-functional collaboration
- Microsoft Office Suite
- Verbal and written communication
Certification
- Assisted in preparation of organization for ISO 14155-2011, ISO 9001-2008, ISO 2001-2013
- Knowledge and training about All analytical and clinical guidelines such as ICH FDA EU & drug and cosmetic act, schedule Y
- Assisted in site preparations for USFDA, WHO, GLP, MHRA, EMA, PHILLIPINS GMP audits for Plant
Languages
English
Hindi
Custom Section
TOPRA MEMBER
Timeline
Regulatory Affairs Consultant
Mundipharma Research Limited
10.2024 - Current
Regulatory Affairs Manager
Farmak Pharmaceuticals UK Ltd
10.2020 - 09.2024
Regulatory Affairs Associate CMC
Sun Pharma ltd
10.2017 - 08.2020
Quality Assurance Trainee
Getwell Pharmaceutical Private Limited
01.2016 - 09.2017
Master of Pharmaceutical Sciences -
Manipal College of Pharmaceutical Sciences
Bachelor of Pharmacy (B. Pharm) -
Manipal University