Senior Associate, Regulatory Intelligence and Analytics

The Associate Director Start Up and Regulatory Affairs oversees and contributes to the day-to-day start-up and regulatory operations, provides input on new business development opportunities, develop and maintain relationships with clients, and provide guidance and support in regards to study start-up and regulatory. Associate Director Start Up and Regulatory Affairs represents a management position in first line of management under direction of Head of Study Start Up and Regulatory Affairs.

Project related

• Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready ensuring all activities are performed within agreed timelines and budgets
• Develops and maintains strategic relationships with customers in alignment with their assigned projects.
• Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. 
• Provide senior level input to client and project specific SSU and regulatory strategy, keeping in mind the overall start up objectives, risk assessment and mitigation plans
• Supports reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times.
• Establishes and maintains training materials for assigned areas.  

Business Development/Proposals

• Collaborates with business leads for business development, contracts, proposals development and project budgets and represent SSU in BD meetings

Line Management

• Provide line management, training and coaching to members of staff
• Manage assignment of workload and monitor performance/utilization
• Review and communicate the need for further recruitment into the department and participate in the selection process as required
• Communicate role, responsibilities, and performance expectations to all members of the team
• Participate in performance review process and provide salary increases promotions or adjustment recommendations for all direct and indirect reports
• Interact with direct supervisors for all indirect reporting personnel to resolve any noted skill deficiencies and arrange for appropriate action to be taken to address problems.
• Deputise for the Director of Study Start Up and Regulatory Affairs

Intelligence

• Develop and ensure appropriate management and maintenance of Regulatory Intelligence.
• Prepare and/or contribute to the Regulatory Newsletter, monthly reports and update regulatory database, slides and trackers as applicable

Audits

• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.

Vendor qualification

• Contribute to the assessment and qualification of new vendors and ensure appropriate training and compliance with company standards. Support ongoing evaluation of existing vendors.

SOPs and company initiatives

• Contributes to and may lead process improvement initiatives across the SSU and Regulatory department.
• Design, implement and ensure compliance of procedures to ensure the smooth running of the division