Experience

SMPL LIFE SCIENCES PRIVATE LIMITED
• India
• Mining
• 1 - 100 Employee
• Manager - Drug Regulatory Affairs

  • Feb 2023 - Present


PREMEDIUM PHARMACEUTICALS PVT LTD.

• India
• Mining

• Assistant Manager - Drug Regulatory Affairs

  • Apr 2019 - Feb 2023

  • Prepare and execute regulatory strategies/plans. Provide ongoing support to product development teams for regulatory issues/questions. • Serves as a departmental knowledge resource, counseling, advising, and training on all/most facets of departmental function. • Responsibility for establishing prioritization of departmental tasks and projects. • Responsible for coordination & preparation of regulatory submissions and strategies for new/renewal & variation filing and manufacturer full registration. • Resolve NOD raised by concerned regulatory agency up to satisfaction. • Review Product development report, Optimization protocol, Optimization Report, Stability protocol, stability report for Dossier Compilation. • Review of Exhibit batch protocol, Exhibit batch report and Exhibit batch manufacturing record. Review of process validation protocol and process validation report. • Preparation and review of ROW documents and submission of documents to Regulatory affairs. • Review Analytical method verification & validation protocol & Report as per ICH Guideline. • Handling of post authorization activity & filling variations dossiers as per variation Guideline. • Preparation of SPC/ package insert /PIL leaflets and to coordinate with art work Department for art work, foil & pack insert. • Review of art works for Dossiers & DMFs (Drug Master Files). • Co-ordination with concerned department for collection of various technical documents Required for Registration. • Archival of technical & administrative documents received from various department. • Sample Arrangement & prepare legal documents required for products registration of the respective country. • Search & review relevant published literature related to clinical & non clinical Data. Registration and variation details transfer to manufacturing facility. Show less



BKRS PHARMA PRIVATE LIMITED

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Executive - Drug Regulatory Affairs

  • Sep 2017 - Mar 2019

  • Development, creation and compilation of International regulatory dossiers for Regulatory Agencies across CIS, Asean, Latin America and various other countries. - Reviewing and preparing the dossier (CTD, ACTD and Country specific) - ASEAN Countries: Cambodia, Myanmar and Philippines - AFRICAN Countries: Uganda, Zambia, Kenya, Chad, Nigeria - CIS Countries: Tajikistan, Uzbekistan, Belarus, Turkmenistan, Kazakhstan and Kyrgyzstan - FWA Countries: Mauritania, Senegal, French Mali, French Guinea, Ivory Coast, Burkina Faso, Benin, Nigeria and Niger - Knowledge of necessary certificates (FSC, COPP, LOA, WHO GMP Certificate, Manufacturing license, etc) • Review of all technical documents for adequacy and accuracy before compilation/submission of dossiers. • Extend complete technical support to the business team, by submitting the Registration Dossiers within the timelines to obtain international market clearances. • Facilitate quick response to technical queries from various regulatory agencies. • Study the Regulatory Requirement and prepare strategy to enter new markets with the help of the business development team. Show less



EAST AFRICAN ( I ) OVERSEAS

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Executive - Regulatory Affairs

  • Oct 2015 - Aug 2017

  • To review and prepare Regulatory Documents • Process validation Protocol & Report • Stability data along with Stability Protocol • Product Development Report • Master Formula Record • Periodic Safety Update Report (PSUR) • Risk management plan • Analytical Method Validation Report • To review and prepare Regulatory Documents • Process validation Protocol & Report • Stability data along with Stability Protocol • Product Development Report • Master Formula Record • Periodic Safety Update Report (PSUR) • Risk management plan • Analytical Method Validation Report