Regulatory Executive at Gesco Healthcare Private Limited (2023-10 – 2025-06)
- Carrying out new product registration activities for CDSCO and CE
- Preparation of Medical Device File and Technical File
- Working collaboration with cross functional teams to align QMS with EU MDR requirements
- Managing QMS Documentation and preparation of standard operating procedures
- Performing internal audits and providing detailed reports to regulatory head & quality department head for compliance enhancement
- Performed systematic literature searches and clinical data appraisal to support the development of Clinical Evaluation Reports (CERs) for implantable medical devices through systemic application of PICO method
- Developed and updated CERs for Class IIb implantable medical devices, ensuring alignment with regulatory requirements
- Collaborated with the Assistant Manager to address customer complaints and prepare comprehensive investigation reports
- Preparing the quality agreements and requesting the procurement department to obtain signatures
- Participated as an auditee in ISO Certification Audit and Surveillance Audit
- Analyzed quality assurance data to identify trends, supporting R&D decisions and generating reports interpretable for regulatory bodies
- Coordinating biocompatibility studies for medical devices in compliance with ISO 10993, managing communications with accredited labs, obtaining quotes, finalizing test plans, and presenting updates to assistant manager & top management
- Served as the primary liaison between internal teams and external laboratories, clearly conveying product specifications to ensure appropriate test selection based on device classification and intended use
- Supporting clients by resolving product and documentation related queries, ensuring smooth project execution and compliance
- Liaising with clients to clarify technical requirements, resolve concerns, and maintain strong professional relationships, while collaborating closely with Sales and Business Development teams to align customer needs with regulatory requirements and product strategies
- Well versed with ICH guidelines
- Timely responding to queries from agencies / clients
- Drafting and distributing client meeting minutes to managers and clients, securing timely review / approval and ensuring regulatory compliance
Jr. Regulatory Executive at Anwita Drugs and Chemicals Private Limited (2023-04 – 2023-09)
- Preparation of dossier especially Module 3 as per latest guidelines of respective regulatory authorities for ROW Market in CTD format
- Preparation of Packing Information Leaflets and Summary of Product Characteristics for drug products
- Coordinate and follow-up with R&D, QA, QC, Production and other cross-functional teams for gathering data for preparation of dossiers for ensuring timely regulatory submission
- Review of all quality documents required for dossier preparation, ensuring accuracy and completeness of data
- Review of BMR, BPR, MFR, MPR and stability documents
- Review of Artworks
- Preparation of various pharmacological and toxicological data based on published literatures
- Review of documents required for regulatory agencies (viz analytical reports, analytical method validation protocols and reports
- Collated and organized data to prepare accurate regulatory documentation, ensuring time submission to commercial partners
Executive - QA at Aurum Pharma Lab LLP (2020-01 – 2021-10)
- Preparation of standard operating procedures and upkeep of quality manual
- To schedule and organize trainings for all employees as per schedule
- Issuance of laboratory note books, log books, formats and maintenance of Quality Control / Microbiology records of analytical activities
- Monitoring and ensuring online documentation of all activities
- Issuance of change controls, deviations and review of change controls and deviations
- Review of analytical documents, specifications and testing procedures
- Coordination with quality head for DQ, IQ, OQ and PQ qualification of instruments
- Preparation of analytical method validation protocols and reports
- Preparation of process validation protocols and reports
- Preparation of COA's to the customers
- Acted as an auditee during CDSCO and NABL certifications
- Conducting internal audits and delivering detailed reports to quality head to improve compliance
Research Scientist - AR&D at Innovare Labs (2018-06 – 2020-01)
- Performed dissolution, assay, content uniformity tests and identification test using instruments such as HPLC, UV-Visible Spectrophotometer and IR
- Performed method validations under the guidance of the Deputy Manager
- Experienced in performing physical tests including disintegration, friability, hardness test and TLC for solid oral dosage forms
- Preparation of specifications and standard testing procedures for drug products
- Collaborated closely with RA team to prepare and submit documents in response to regulatory queries
- Implementing 5S activities in the lab
