Director, Regulatory Affairs
Pharmaceutical Product Development, Inc. - Morrisville, NC

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Director, Regulatory Affairs


              Job Category Regulatory Affairs
              Primary Location North America-United States-North Carolina-Morrisville - 1800 Perimeter

              The Director, Regulatory Affairs provides direct management and support to members of Regulatory Affairs Development. Responsible for all budgets and contracts in relation to their assigned projects. Executive contact for the sponsor. Provides regulatory advice on strategy and manage projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. Oversees/ensures all aspects of Regulatory Affairs are conducted in accordance with sponsor companies' requirements.

              This position primarily ensures the day to day operation and management of assigned regulatory services, in accordance with contract, all applicable regulatory requirements and laws, and sponsor/PPD polices and procedures. Works globally to develop new business and to deliver existing business in order to meet PPD's business goals. *LI-TJ1


              Education and Experience:
              • Bachelor's degree in a science related field
              • 10+ years regulatory experience
              • 5+ years of management experience
              • Proven leadership and supervisory skills

              Knowledge, Skills and Abilities:
              • Broad regulatory affairs experience
              • Excellent knowledge of Global Regulatory Procedures, including both clinical trials and product licensing
              • Proven success in agency influencing and negotiation
              • Expert knowledge of ICH and global regulatory guidelines
              • Good in-depth knowledge in one of the specialist areas; preclinical, CMC, clinical
              • Ability to motivate and integrate teams and teach/mentor team members
              • Ability to discipline and reward employees and perform timely, effective performance evaluations
              • Excellent judgment and decision-making skills
              • Effective organizational, planning and negotiation skills
              • Proven ability to work effectively in a team environment
              • Excellent interpersonal skills and problem solving ability
              • Effective oral and written communications skills
              • Ability to act as a liaison with other departments where necessary
              • Knowledge of budgeting and forecasting
              • Good computer skills such as Word, Excel and PowerPoint

              PPD is an Equal Opportunity Employer

              Job Posting

              About this company
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              PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services....