Associate Regulatory Affairs Director

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE
Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with SOPs, policies and practices.

RESPONSIBILITIES
•May act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation. Undertakes risk analysis, management and contingency plans, as appropriate.
•Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate.
•May manage meetings with Regulatory Agencies.
•May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients.
•Provides mentorship to junior colleagues and advise others on many regulatory document types.
•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 tasks or assignments, as delegated by Regulatory management.
All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Extensive experience in regulatory and/or technical writing
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 customers
Strong software and computer skills, including MS Office applications
Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
Ability to exercise independent judgement taking calculated risks when making decisions

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
•Degree in life science-related discipline or professional equivalent plus at least 8 years relevant experience* including 6 years regulatory 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

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.