Neha Tembe Email & Phone Number

India

Mumbai, Maharashtra, India

Mumbai Area, India

Mumbai Area, India

 Responsible for co-ordination and preparation of regulatory submission (variations and renewals) and communicate effectively with regulatory authority to obtain timely approval for European Market.  Responding to the queries from various European health authorities within predefined time with adequacy and accuracy. Submitting variations and renewals through CESP (Common European Submission Portal). Effective communication with regulatory agencies for resolving issues regarding… Show more  Responsible for co-ordination and preparation of regulatory submission (variations and renewals) and communicate effectively with regulatory authority to obtain timely approval for European Market.  Responding to the queries from various European health authorities within predefined time with adequacy and accuracy. Submitting variations and renewals through CESP (Common European Submission Portal). Effective communication with regulatory agencies for resolving issues regarding the submissions. Managing a team of several regulatory executives.  Experience in e-CTD and Nees publishing. Tracking safety updates of the product information. Tracking monthly output of the team for management’s review. Show less

Mumbai Area, India

 Preparation of CTD dossiers for Canada, dossiers for WHO prequalification with tender documentation, technical query response for generic products application.  Organization & provision of questionnaires, technical documents & samples for tenders to various institutions Checking of product artworks as per the registration packaging / labeling guidelines of the country for product registration & export consignment. Review and analyze the technical quality documents on receipt… Show more  Preparation of CTD dossiers for Canada, dossiers for WHO prequalification with tender documentation, technical query response for generic products application.  Organization & provision of questionnaires, technical documents & samples for tenders to various institutions Checking of product artworks as per the registration packaging / labeling guidelines of the country for product registration & export consignment. Review and analyze the technical quality documents on receipt from necessary stake holders before inclusion in dossiers. Effective communication with respective consultants of Canada & various institutions for resolving registration issues for more clarifications. Application of legal documents such as manufacturing license, Certificate of Pharmaceutical Products, Free Sale certificates etc required for registration. Liaison with the relevant in-house departments for collection of various technical documents as required for registration & tender purpose. Show less

Mumbai Area, India

 Responsible to deliver regulatory communications to the internal and external customers Responsible for effectively and efficiently support global business objectives Preparation of regulatory submissions and documentation (renewals and subsequent variations to UK, Ireland, Germany, Luxemburg, Malta etc) Responsible for solutions to the queries received from regulatory bodies (MHRA - UK, IMB - Ireland) Management of artwork related activities as per the guidelines… Show more  Responsible to deliver regulatory communications to the internal and external customers Responsible for effectively and efficiently support global business objectives Preparation of regulatory submissions and documentation (renewals and subsequent variations to UK, Ireland, Germany, Luxemburg, Malta etc) Responsible for solutions to the queries received from regulatory bodies (MHRA - UK, IMB - Ireland) Management of artwork related activities as per the guidelines specified by specific country’s regulatory body. Dossier preparation as per country specific formats for Thailand and Sudan Management of Projects: Updating artworks as per the Guidelines given by MHRA (excipient Guidelines) Responsible for training one regulatory associate in the daily activities Show less