RND Scientist Job

RND Scientist is needed to perform the following duties :

• Review and submission of high-quality NDA, ANDA, pre-IND meeting requests, Controlled Correspondences submissions.
• Co-ordinating with CMO’s for tech-transfer submissions.
• Evaluating change controls and providing regulatory assessment.
• Review and compile post approval submissions like supplements, annual reports.
• Review and compile deficiency letter responses.
• Managing the internal team in developing innovative regulatory strategies during the pharmaceutical drug development
• Developing SOP’s and Regulatory guidelines for the internal team.
• Monitoring of the labeling team from drafting stage to the implementation stage.
• Serve as a regulatory advertising and promotion reviewer for assigned products.
• Following up with the CMO’s to ensure timely and quality regulatory submissions.
• Organize and update Regulatory files in internal drives.

Bachelor’s degree is required in Pharmaceutical Science or Pharmacy.