Director Clinical Trials Regulatory Management

PURPOSE

Using broad management discretion, direct, oversee and manage complex, regulatory project(s), ensuring quality deliverables on time and within budget. Ensure that all work is completed in accordance with SOPs, policies and practices.

RESPONSIBILITIES

• Building relationships with African regulators and ECs
• Engage with regional stakeholders (e.g. African union, Africa Medicine agency, etc.) to discuss harmonisation efforts and support ecosystem shaping activity
• Assist with regulatory intelligence gathering and advisory, for both internal and external purposes
• Collaborate with global CTRM colleagues to maximise understanding of global process and structure of both external and internal regulatory arena to support harmonisation and development of best practice
• Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate.
• May act as a regulatory oversight for a key customer. Responsibilities will include agreeing clinical trial regulatory processes, managing escalations and identifying solutions to challenges that are acceptable to IQVIA and the customer
• May strategically plan and perform centralised European submissions and facilitate global submissions for complex studies and programs
• Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans.  Continually looks for process improvements.
• May take a leadership role in bid defense strategy and planning, as appropriate
• Deliver presentations/training to clients, colleagues and professional bodies, as required
• May act as a Project Manager for a stand-alone project.
• May act as regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
• May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development
• 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
• Excellent ownership and oversight skills
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Strong software and computer skills, including MS Office applications
• Possesses an acute awareness of issues out with the business function. Exudes confidence and authority within remit, delivering a positive example to project teams
• Remains motivated and enthusiastic in times of change and other pressure situations
• Demonstrated ability to seek and apply industry trends within functional areas of expertise; conscientious of marketing opportunities

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 10 years relevant experience* including 8 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