Associate Director, Regulatory Affairs

Key Responsibilities

• Clinical Trial Regulatory Submissions: Over 15 years of relevant experience in clinical trial regulatory submissions.
• Regulatory Leadership: Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure to the European market.
• Database Expertise: Proficiency in handling the CTIS database and submitting EU CTR and CDSCO is desirable.
• Project Profitability: Monitor the profitability of multiple projects/programs through active involvement with project leads in preparing project plans and managing project budgets.
• Revenue Recognition: Proactively avoid and resolve issues with revenue recognition.
• Team Collaboration: Work within a team environment or individually based on project needs.
• Mentorship: Provide guidance to project team members and act as a mentor to staff.
• Issue Resolution: Work within broad project guidelines and lead issue and conflict resolutions.
• Workload Management: Prioritize own workload and the workload of the project team to achieve project scope and objectives.
• Efficiency Improvement: Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
• Performance Management: Actively manage performance, including typical HR activities for direct reports (e.g., performance management forms, salary actions, bonuses, scorecards).
• Staff Support: Provide input on staff to appropriate PC Members and support direct reports with the management of their staff.
• Guidance and Accountability: Provide applicable guidance and support to staff to succeed and achieve key metrics; hold staff accountable to key metrics.
• Staff Development: Facilitate staff development plans and coordinate with Strategic Resourcing staffing to ensure staff is utilized completely and appropriately to increase their expertise.
• Skill Expansion: Collaborate with strategic resourcing to provide staff with opportunities to expand skill sets.
• Recognition and Reward: Reward staff appropriately as needed.
• Leadership and Mentoring: Provide leadership, coaching, mentoring, feedback, and role modeling to managers and extended staff to ensure quality and accuracy of services as well as achievement of key metrics.
• Vision and Values Communication: Communicate and champion organizational vision and values.
• Effective Communication: Regularly communicate with staff to assure effective two-way information flow (e.g., business updates, staff interests, issues, and/or concerns).
• Consulting Services: Provide a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear.
• Self-Development: Define self-development activities to keep current within the industry (e.g., maintain membership in a relevant industry and/or scientific/technical association).
• Project Efficiency: Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
• Information Leverage: Leverage information from previous projects or other client work to efficiently complete assigned project activities and facilitate business decisions.
• Quality Work: Produce quality work that meets the expectations of the client. Review the work of colleagues for content and quality to ensure client and PC expectations are met.
• Strategy Development: Assess project issues and develop strategies to meet productivity, quality, and project goals and objectives.
• Performance Management: Actively manage performance, including typical HR activities for direct reports (e.g., performance management reviews, salary actions, bonuses, scorecards)