Head- Drug Regulatory Affairs

I am Graduate in Pharmaceutical Science with 8 years of rich experience in Drug Regulatory Affairs Department. Working currently for registration of Pharmaceutical Products for oral Administration. I have been working for Registration of oral formulations in Regulated, CIS, ASEAN, SAARC, and ROW market. Preparation/ Compilation and filing of Product Dossiers along with required samples as per CTD/ACTD Formats along with the country specific requirement for registration of Pharmaceutical Products within defined timelines. Successfully preparation and submission of Expert Review Panel application for Prequalification of WHO Geneva and involve in Registration of Product Dossier in Geneva. Involve in Compilation and review of ANDA (02 Products) Dossier for successful registration of Pharmaceutical Product in USFDA. Review of documents like API's DMF, finished product specification, Certificate of Analysis, PDR, BMR, Process Validation and Stability data etc. for guidelines compliance. Coordinate, prepare, or review regulatory submissions for domestic or international projects. Handling queries with the regulatory authorities in the country. Preparation for Summary of Product Characteristics, Package Insert literature of the products. Managing the product life cycles from initial submission, query resolution, approval of submitted drug product and related re-registration activity. Specifying storage, labeling and packaging requirements. Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts for smooth registration. Ensure to obtain the regulatory permits on time, in support for the organization's business requirements.