-Ensuring the objectives of individual staff and teams are in line with overall Regulatory Affairs objectives by facilitating regular communications.-Certified Trainer-Meets with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to both the study team and sponsor.-Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensuring that revenue is recognized and challenges when appropriate.-Presents to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables.-Writes new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures.-Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs.-Responsible for leading moderate to significant improvements of processes, systems or products to enhance performance of job area.-Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.-Designs training materials and deliver training externally and internally.-Manages assembly and submission of applications to regulatory bodies including FDA, Health Canada, EMA, UK, Africa and Middle East-Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations-Primary or secondary regulatory responsibility for assigned projects by providing to the project teams regulatory information, guidance, training, support and strategic planning-Keeps abreast of, interprets, and communicates applicable regulatory regulations and statutes with internal departments and ensures IQVIA Biotech compliance

Manage the workload of the client deliverable documents that need to undergo the Quality Control process. Serve as a Team Leader for client deliverable documents that will need to undergo the Quality Control process. Prepare a plan for the Quality Control staff to follow for each project dependent on the specifications for each client. Provide training for the staff for each project and provide overall Quality Control training to new employees or staff within other departments. Monitor and track the progress of each project. Ensure that all staff adheres to the plan set in place for each project. Resolve any problems that arise for each project. Monitor the quality of the output of the department. Provide assessment to Medical Writing management on the quality of the output from the Medical Writers. Provide updates to the staff on the progress of the projects. Reviews documents to ensure “Regulatory Compliance” with GCP, ICH, FDA, and EU guidelines and recommendations. Prepare Audit Reports for each project at the conclusion. Review all responses to the findings in the Audit Reports. Review all documents that are required. Track all staff billable time. Develop and implement new Quality Control Standard Operating Procedures and training. Prepare and submit to clients and/or health authorities electronic regulatory submissions. Compile regulatory submissions, e.g. INDs/CTAs and NDAs/MAAs. Archive regulatory documents (in both paper and electronic formats) in accordance with standard operating procedures. Review regulatory documentation required for the initiation of clinical trials for appropriateness, completeness, and compliance with applicable regulations. Remain current with changing regulatory requirements.

Verifying that rates are correct. Send rate sheets out to all of our Correspondents. Sending FYIs out to all Correspondents. Assisting with phone volume when necessary. Creating new rate sheets and verifying that they are correct. Updating fax numbers in our database with who does/does not receive rates. Supervising the rate Co-Ordinator. (Making sure everything is complete.) Verifying various web site rates.