Director, Regulatory Affairs

PURPOSE Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorization activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.

RESPONSIBILITIES • Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate. • Competently writes regulatory and/or technical documents with minimal review by senior staff. • Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues. • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognized and challenges when appropriate, may seek guidance from senior staff as appropriate. • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development. • May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff. • May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate. • May be involved in a Regulatory and/or Quintiles Initiative. • Performs other tasks or assignments, as delegated by Regulatory management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • • • • • • Demonstrates comprehensive regulatory or technical area of expertise Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach Strong software and computer skills, including MS Office applications Demonstrated skills in chairing small meetings Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision Ability to propose revisions to SOPs or suggest process improvements for consideration


MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)

PHYSICAL REQUIREMENTS • • • • Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time Travel will be required

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