狠狠撸

Vadodara Area, India India

Regulatory Affairs Associate at Harson Laboratories

Preparation of Regulatory dossier European and Asean market. Submission of Product permission Preparation and troubleshooting query, state FDA and regulatory audit. Preparation of APQR BMR/BPR review site audit IPQA Documentation/sop Having experience of clinical trials,.Coordinate with CRO and different study trial along with regulatory documents. Also involve in BA/BE (Phase:I-III) studies. Collecting source documents, evaluating datas, filling eCRF. Patient Counselling and managing all required regulatory documents. ICH GCP Training of Site Staff and Investigator. Monitoring drug accountability and temperature log. Communication with Sponsor, Monitors and third party. Maintaining...