Veena Gupta
Regulatory Affairs Supervisor
Noida
Summary
Dynamic Regulatory Affairs Supervisor at Guerbet India Pvt. Ltd., skilled in global regulatory compliance and stakeholder management. Successfully led drug and medical device registrations, ensuring timely approvals. Expertise in quality assurance and vigilance, with a proven track record of implementing corporate SOPs and driving continuous improvement in regulatory strategies.
Overview
10
10
years of professional experience
4
4
Certifications
2
2
Languages
Work History
Regulatory Affairs Supervisor
Guerbet India Pvt. Ltd
08.2022 - Current
- Supported the implementation of corporate SOP and Local SOP development on GDP and GDP certification and maintenance
- Handled quality related questions and complaints
- Supported in documentation in Importation and custom clearance and internal audit
- Successfully completed single-handed corporate QA audit in Nov 2023
- Performed Quality system audits for distributor, services providers with guidance of APAC Quality Manager
- Driven drug and medical device registration and variations or verification in accordance with relevant regulation and develop the strategy to obtain the product approval within targeted timeframe
- Performed class III and IV voluntary and mandatory registration
- Registered sites and products in within timeline and before targeted timeframe
- Keep updates/ information of regulatory procedure and product changes to ensure products documents are maintained in compliance with local and corporate instruction
- Supported business partner or registration in Bangladesh, Srilanka, Nepal etc
- For drug and medical devices
- Effectively communicate and collaborate with regional/corporate RA and commercial team in order to develop Regulatory Strategies & to provide local regulation intelligence to internal stakeholders
- Maintenance of registration data base locally
- Maintained contact with the DCGI & CDSCO regulatory authorities & to melt and be in touch with the local regulatory office to keep updated on the latest happenings
- Work along with the local regulatory liaison agent for smooth execution & handover process
- Supported regulatory cost related subjects like forecasts and latest updates fee structure in collaboration with commercial
- Supported and expedited clinical trials and Phave IV study
- Implemented locally the group RA policy, Strategy and objectives as defined by Head of Regulatory Affairs
- Managed the tasks for regulatory affairs, Pharmacovigilance, Promotional material review on regulatory perspective and support the quality assurance
- Maintained contact with local consultant, regulatory authorities
- Managed task for promotional material review with commercial team etc
- Responsible for Pharmacovigilance and Materiovigilance including reporting/communication with HQ and authorities on time
- Implemented corporate SOP, maintained local PV and MDV system and updated local SOPs
- Ensured all PV related submission are made & updated on time, in coordination with the HQ team, regional team and in country team
- Successfully completed single-handed corporate Vigilance audit in Jun 2023
- Ensure company's products comply with the regulations
- Validation of promotional material and packaging materials in compliant with local regulation and corporate policy
Sr. Specialist- Regulatory Affairs
Amarant Lifescience Pvt. Ltd
03.2021 - 06.2022
- Working closely with different Clients/companies, doing planning and implementation of regulatory strategies in collaboration with Team for filing of various licenses and applications as per the Project assigned
- Steering the compilation, review and SUGAM filing of technical documents/dossiers of Medical Device /Biological divisions and drug division for registration as well as import applications
- Providing leadership for ensuring that compliant regulatory strategies are developed in alignment with business objectives and implemented within timeline; liaising with top management and other departments to design regulatory strategies
- Reviewing and loading new product listing, product delisting, registration of new manufacturing sites into the registration & listing databases for India and Europe
- Completing inquiries and requests from internal and external sources in regard to import/export processes
- Reviewing and approving/disapproving labelling change request, advertising and promotional request, field communications in accordance with regulations and guidelines
- Liaising with external / internal customers to meet regulatory requirements with respect to drug formulations development, analysis and manufacturing
- Reviewing R&D data, analytical data and other DMF related requirements with feedback capability to comply with the requirements during product development and registration
Senior Executive- Regulatory Affairs
Evolet Healthcare Pvt. Ltd.
12.2016 - 01.2021
- Established & implemented regulatory strategies via telecons with clients; communicated details regarding collecting data & compiling the basic information towards the preparation of dossiers for filing of Medical devices/IVD
- Compiled, reviewed & filed online SUGAM for technical documents/dossiers of Medical devices/IVD
- Conducted regular follow-ups with DCGI &CDSCO for all kind of applications about Biologicals, Drug, Cosmetics, Medical Devices Registration Application
- Managed labelling compliance for imported products of Medical Devices/IVD
Executive- Regulatory Affairs
East African (India) Overseas
05.2015 - 12.2016
- Prepared & reviewed: Dossiers basis existing prescribed guidelines of the CDCSO and regulatory authorities
- Led the registration of pharmaceuticals across ASEAN (ACTD) countries, including Vietnam, Cambodia, Sri Lanka, Philippines, Myanmar, and CIS (CTD) countries like Kazakhstan, Georgia, Uzbekistan, Tajikistan, Kyrgyzstan, Ukraine, FWA countries, Niger, Burkina Faso, Mali, etc
- Managed the preparation of: Pharmaceuticals, Ayurvedic/Herbal, Cosmetics and Nutraceuticals dossiers for various semi regulated and non-regulated countries like Philippines, Jordan, Sudan & UAE
- Periodic Safety Update Report (PSUR), SAE submission, local literature search, co-ordination with physician and training of salesforce
- Review of documents required for regulatory agencies (viz., analytical reports, process validation reports & protocol, pharmaceutical development report & protocol and stability data)
- Preparation and review of SPC, package insert and labeling information for drug products
- Review of artworks of Pharmaceutical Products
- Responsible for resolving query regarding from Regulatory Authorities
Education
M. Pharma. - Pharmaceutical Chemistry
Banasthali University
RajasthanB. Pharma. - undefined
Gautam Buddha Technical University
LucknowSkills
Global Regulatory Affairs
Certification
US Regulatory strategy for Biologics and Pharmaceutical drugs, Udemy
Personal Information
Date of Birth: 06/01/88
Presentations
- Phytochemical Investigation and Development of Microwave assisted extraction method of Cassia aucriculata, National Seminar-2013, Jaipur
- Indian Science Congress Association sponsored National Conference, Meeting the Challenges of Water and Energy, Banasthali University
- European Regulatory and Quality Summit 2019, 11/14/19, The Park, New Delhi
Publications
- Biomarker: A Comprehensive review, Bulletin of Pharmaceutical Sciences, Veena Gupta, Ekta Singh, Swapnil Sharma
- Regulatory Canvas of Indian Pharmaceutical Industry: Challenges and Future, Pharmatutor, Veena Gupta, Ayushi Srivastava
Training
- UP Drugs & Pharmaceutical Ltd., Lucknow, 1 Month, QA/QC
- Albert David Ltd., Ghaziabad, Uttar Pradesh, 1 Month, QA/QC
Accomplishments
Active participation in Guinness world records held by Guerbet India on Largest Radiology Lesson multiple venues
Timeline
Regulatory Affairs Supervisor
Guerbet India Pvt. Ltd
08.2022 - Current
Sr. Specialist- Regulatory Affairs
Amarant Lifescience Pvt. Ltd
03.2021 - 06.2022
Senior Executive- Regulatory Affairs
Evolet Healthcare Pvt. Ltd.
12.2016 - 01.2021
Executive- Regulatory Affairs
East African (India) Overseas
05.2015 - 12.2016
M. Pharma. - Pharmaceutical Chemistry
Banasthali University
B. Pharma. - undefined
Gautam Buddha Technical University
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