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Seema J
@seemaj18
REGULATORY AFFAIRS LEAD
Inde
Anglais
À propos de moi
Regulatory Affairs Specialist with 9 years of experience in the pharmaceutical industry, including with a proven track record of supporting global regulatory submissions, tender bid processes, and compliance for both regulated and semi-regulated markets. Adept in leveraging key regulatory tools and platforms such as Veeva Vault, REDS, ORION, CAST, Amplexor, and Darius System to drive submission accuracy and streamline documentation workflows. Demonstrated expertise in: Regulatory planning, authoring, and quality assurance of dossiers, Data collation and quality control.
Compétences
Seema J
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Certifications et réglementations
I will provide regulatory affairs, rims and pharma documentation support
Sécurité des produits et certification de la qualité
I will perform regulatory documentation review and dossier assessment
Expérience professionnelle
LEAD ASSOCIATE
Genpact • Temps plein
Apr 2022 - Present • 4 yrs 2 mos
TAKEDA RIMS Project (1-Oct-2024-till date): 1. Currently perform Data enrichment & cleansing activity of Events & RO’s for RIMS Data transfer. 2. Successfully completed enrichment and migration of Data from Sprint 1 to Sprint 7 within set time frame with the support of excellent colleagues. 3. Doing enrichment as well as review of RIMS information related to the components/joins of the Veeva Vault application (such as Drug Product, Product Variants, Complex Product Components, Events, Medicinal Products, Medicinal Products Full Name, Medicinal Products Part Name, All Event Joins, Medicinal Product Registration). 4. Attending client meeting on daily basis to resolve migration/ enrichment related issues/queries. 5. Performing high quality QC of enriched data. 6. Supporting team members in day‐to‐day activities and resolving queries of them. 7. Resolving internal QC comments. 8. Hands on experience in Regulatory tools like Veeva Vault. MERCK Project (22-April 2022-30-Sep-2024): 1. Manages all activities involving planning, procuring, coordinating, authoring setup format, reviewing, dispatching the package to the requestors and Archival of the Tender Bid submission packages. 2. Responsible for handling of Tender Bids requests by reviewing, logging. Monitors progress, and tracks completion. Surveys the markets quarterly to obtain list of new tender bid requests. 3. Oversight of Tender Bids requests to ensure we meet required timelines. Involved in Data Collation and Compliance Assessment activities as a part of CMC compliance project for a major pharmaceutical company for Semi- regulated (ROW- African & ASEAN) & Regulated markets. 4. Performed QC/ QA- review of compliance assessment. Reviewed various technical documents like Batch Manufacturing Records, Release and Shelf- life specifications, method of analysis, Process validation protocols & Reports, Analytical method validations, Stability protocols & Reports and Packaging Specification.
QC TRAINEE
SG PHARMA • Temps plein
Jul 2016 - Dec 2016 • 5 mos
a. Prepare Intimation As per IP, BP & USP Monograph for the products. b. Calibration of Balance & pH Meter. c. Checking of Reports & their Limits. d. Calibration of Dissolution. e. Water Analysis. f. Keeping Records of Reagents.
JR ANALYST
USCPL • Temps plein
Jun 2015 - Jun 2016 • 1 yr
a. Analysis of Raw material & Finished Product of Agro. b. Analysis of waters sample. c. Calibration of instruments. d. Documentation and compiling of results & methods of analysis as per GLP. e. Preparation and analysis of Various Agro based product.
