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ProfileRegulatory Associate Responsibilities: Develop and maintain regulatory strategy for CT material labels, Expanded Access Programs, Import/Export requirements, and clinical trial material regulation. Propose updates to process and procedures as regulations change to ensure compliance. Provide high quality and timely regulatory advice on CT material regulations to allow business partners to make well-informed decisions. Contribute to impact assessments on evaluation of regulation changes driving solutions that meet needs of the affiliate and the business. Work collaboratively to handle issues, propose mitigation/response plans to resolution and effectively implement action plan for regulatory challenges/issues. Participate in interpretation and implementation of regulations impacting CT Material across Product Delivery, Clinical, and Regulatory organizations through dedicated and effective communication. Contribute and participate in periodic regulatory reviews of country regulations. Craft and participate in change controls when standard processes must be modified or changed. Stay abreast of cGMPs, GDP’s, GCPs, and other regulatory requirements related to CT material.
Qualification and Experience
Qualifications: Bachelors degree. RPh, PharmD or JD Degree. TrackWise Experience. Industry-related experience in regulatory affairs and/or drug development preferred. Experience with devices in pharmaceutical drug delivery. Knowledge of global regulatory procedures and practices and awareness of evolving regulatory reforms and initiatives; ability to assess regulations in multiple countries. Strong proficiency with computer applications including Outlook and Microsoft Office. Strong interpersonal and networking skills, including capability to engage in professional relationship building. Ability to manage multiple tasks, strong organization, and self-management skills. Working knowledge of GCP regulations, MQS, and GMP/GDP requirements. Knowledge of Clinical Trial and Protocol Design. Knowledge of procedural and regulatory standards.
Job Expires: 04-Oct-2018
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285