Senior - Director - Regulatory - Quintiles - Raleigh-Durham

Job description
Line Management responsibilities for multiple Regulatory Affairs sites and/or region. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs and Corporate 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.
• Collaborates with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for regulatory projects. Continually looks for process improvement, seeking new ideas and ensuring open communication with staff. May participate in or lead corporate or departmental quality or process improvement initiatives.
• Contributes to or may lead discussions to define global strategy and may lead implementation on a regional or global level, ensuring staff have a thorough understanding of the strategy and its application.
• Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites by analyzing and reviewing financial reports.
• May act as a global contact or lead for a specific customer.
• May take a proactive role in developing long standing relationships with preferred Quintiles customers, and may take a leadership role in bid defence strategy and planning, as appropriate.
• Ensures compliance of RA processes and prepares for full RA Systems Audits; accountable for any subsequent action plans. Continually looks for process improvements.
• Competently manages meetings/expectations with Regulatory Agencies and/or groups within Quintiles.

Desired Skills and Experience
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for meeting regional or global objectives.
Strong, proven leadership skills and the ability to work effectively with senior management and delivers positive messages to staff
Ability to make difficult judgment calls within sphere of responsibility. Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within Quintiles and customer organization
Act as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations
Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit
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 12 years regulatory experience including 8 years management experience (*or a combination of education, training and experience)
SMEs with BLA / CBER experience

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