Associate Director, Regulatory Affairs

IQVIA•Washington, DC

23h

About The Position

Job Overview 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 standard operating procedures, policies and practices. Essential Functions 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 standard operating porcedures or cross-functional standard operating porcedures 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;

Requirements

Bachelor's Degree Degree in Lifescience or related discipline Req Or Master's Degree Degree in Lifescience or related discipline
At least 8 years relevant experience including 6 years regulatory experience or combination of education, training and experience
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
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

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 standard operating porcedures or cross-functional standard operating porcedures 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