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Regulatory Affairs Director - (1803951) in Durham, NC at IQVIA™

Date Posted: 2/13/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
    Regulatory
  • Experience:
    At least 6 year(s)
  • Date Posted:
    2/13/2018
  • Job ID:
    1803951

Job Description

Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

Description

PURPOSE
 
Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs business plans. Participates in project-related work, as necessary.
 
RESPONSIBILITIES
 
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration.
• Independently handles personnel issues, conflict management, defines goals that increase knowledge and skills of staff, and defines staff expectations, without involvement of senior managers.
• Assists in the coordination of projects and resources, ensuring quality deliverables to customers.
• May contribute to discussions on implementation of business strategy on a regional basis and will set and implement site-specific objectives, as appropriate. Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives.
• May have financial responsibility and accountability for one or more Regulatory Affairs sites. Undertakes business development activities and monitors growth and performance, as required.
• May undertake risk analysis and manages the outcome as appropriate.
• Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs.
• May act as a Project Manager for a large stand-alone program, involving several regulatory or technical deliverables and/or region, and/or operation. May provide strategic regulatory and/or technical consultancy on a variety of projects.
• May manage meetings with Regulatory Agencies.
• May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients.
• May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications.
• May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations.
• May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative.
• Performs other duties, as business needs require.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
  • Line management experience required, with demonstrated success in staff development, engagement, and performance
  • Ability to manage competing priorities, as appropriate
  • Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with staff and customers
  • Sets a positive example to more junior staff relating to professionalism, positive attitude and communication style to customers and colleagues. Communicates effectively and confidently with various levels of the organization, as appropriate; remains motivated and enthusiastic in times of change and other pressure situations
  • Ability to exercise independent judgement taking calculated risks when making decisions
  • Sound financial awareness
  • Strong software and computer skills, including MS Office applications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Degree in life science-related discipline or professional equivalent* plus at least 6 years regulatory experience including 3 years management experience (*or a 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
 
EEO Minorities/Females/Protected Veterans/Disabled

Job ID: 1803951