Manager, Global Regulatory Project Management

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:Primary Role Coordinate, manage and direct all aspects of global regulatory projects from early stage development through post approval and life cycle management. Maintain and update the global program database consisting of program plans, timelines, and status reports to senior management. Work with cross functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functions issues associated with specific projects, driving the completion of action items as well as support the resolution of issues. Responsibilities Work with project teams to prepare the submission plan that defines content, assign project responsibilities, determine the project timeline, and senior management review and approval Maintain and update global regulatory program database and related reports Actively participate and present in various program team meetings, obtain updates from various team members in order to track progress being made on the program against set timelines, notify management of critical issues and update timelines/database as appropriate Prepare and manage the consolidation of critical project information to assist in decision making Review and manage project timelines to ensure regulatory documentation meets the defined timelines and content requirements and that milestone dates are met by contributors and reviewers for timely VP review and approval of submissions Generate routine status reports to appropriate groups and senior managementShire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: Education & Experience Requirements BS/MS in scientific discipline plus a minimum of 5 years of relevant experience in regulatory affairs or program management in the pharmaceutical industry.Key Skills and Competencies Incumbents at this level are involved in a variety of diverse scope and complexity, which require thorough and practical solutions. Need to have excellent organizational skills, attention to detail, ability to communicate across all levels of an organization. Ability to deal successfully with complexity of issues. Apply to Shire