Experienced Drug Regulatory Affairs Executive for Ipca Laboratories, Mumbai, D 7

Position: Regulatory Affairs Executive

Job Description

•Reviewing BE study protocols received from CRO and ensuring its completeness with respect to scientific and regulatory requirements. •Reviewing in vitro dissolution data received from R & D in line with the available guidance. •Reviewing draft and final BE study report and ensuring its correctness as per applicable regulatory requirements. •Maintaining BE study related documents for respective studies. •Perform monitoring visit at CRO to verify source documents. •Monitor the progress of study and ensure the timelines as per the agreed task order. •Finalizing study specific task order with the selected CROs. •Co-ordinate with the CROs for proper execution of BE studies. •Responsible for handling regulatory queries. •Responsible for overall conduct and management of BE activities. •Co-ordinating for import license and BE NOC with the regulatory team. Experience: 2- 5 Years Salary: As per Industry standard Multiple positions Desired Profile: M Pharm/ B. Pharm Apply Directly to Company website