Associate Regulatory Affairs Director
Descripción del trabajo
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, possible line manager.
- Acts as a Regulatory Advisor on complex clinical trial projects/programs and may act as a Regulatory Oversight for a key customer.
- May act as a Project Manager on stand-alone projects
- Interacts with internal, external clients and professional bodies and/or delivers presentations/training to clients, colleagues, as required
- May strategically plan and oversee global country submissions for complex studies
- Provides innovative solutions where appropriate and competently manages meetings and expectations while being able to influence positively project teams and/or customers
- Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate.
- May write and/or review a single service regulatory proposal and/or the regulatory component of a full-service proposal and defend costs and timelines to clients.
- Provides mentorship and support to junior colleagues.
- May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good understanding of the regulations, directives and guidance supporting clinical Research and Development
- Demonstrates comprehensive regulatory/technical expertise
- 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
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Ability to exercise independent judgement taking calculated risks when making decisions
- Excellent ownership and oversight skills
- 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
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)
- 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
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Únase a la red de talentos de IQVIA
Regístrese hoy y le informaremos cuando haya puestos disponibles que coincidan con sus intereses profesionales.Únase a nuestra red