- Address SUTHAR FALIYA, HALOL- DIST-PANCHMAHAL -389350 (GUJARAT)
- Language English, GUJARATI , HINDI
- Highest Degree Level M.Com
- Total Years of Experience 5 - 10
- Expected Job Level Entry Level / Fresher
- Regulatory AssistantSun Pharmaceutical Industries Limited, Halol
Local FDA related work: -1. Test licence procurement and management and Product permission procurement and management2. Request for Application to India-RA (Regulatory Affairs) for identified product, coordination with India RA (Regulatory Affairs) Team and tracking.3. Receipt of original product permission, Entry in Excel sheet, scan and file the original copy and Database updation.4. Providing to respective department whenever request.5. Application for the renewal and following procedure as mentioned above.WHO Inspection Proposal and approval activity1. Providing documents necessary for the Application.2. Correction (addition or deletion) of product list.3. Providing final product list for the renewal to India-RA (regulatory affairs) for the final application in consultation with CRA (Corporate regulatory affairs).Manufacturing licence renewal activity Wholesale licence renewal activity1. Providing documents necessary for the Application.2. Correction (addition or deletion) of product list.3. Providing final product list for the renewal to India-RA (regulatory affairs) for the final application,database updation.Sample management for local FDA request1. Upon receipt of request from FDA (Food and Drug Administration) inform to respective department for the samples.2. Request for the Analytical documents, Sample arrangement, courier and retrieval of documents. Activities related to Technical person approval and supervisory chemist1. Request to respective department head for nomination of person for technical person approval,sending form.2. Receipt of filled form and respective documents, Review the form for the completeness.3. Providing the final documents to India -RA (regulatory affairs) for the application at FDA (Food and Drug Administration), archival of certificates.4. Providing List of approved technical person list during Inspection.Layout approval from FDA1. Receipt of approved layout copy, file and track.2. Providing the layout during inspection.3. Others activities
Support in routine RA related activities1. Preparation of Summary of In - process parameters and product reconciliation from BMR (batchmanufacturing record) for submission in dossier.2. View data and prepare reports from ERP system. (METIS) (Stock checking, RM (raw material), PM(packing material) Data sheet generated from METIS).3. Audit supported work.4. Scanning of documents. (Certificates for Emerging markets, regulated market (Declarations, c GMPCertificates, Commitments etc )5. Help in Management of Registration samples for emerging market (EM).6. Database management for Approval package of emerging market (EM)7. Preparation of summary of APR (Annual product report) from eCTD (Electronic Common Technical Document).8. Preparation UID's (Declaration) - the year wise all products.9. New person joining all help of (taken system, email ID, Window login ID, telephone etc…)10. RA (regulatory affairs) department all print out of documents.Project: -1. I handle special project for Regulatory Documentation as per product permission and test licence requirement2. Product permission re – arrangement and implementation.