Regulatory Affairs Director

3 weeks ago

Bengaluru, Karnataka, India Parexel Full time

About the Role

Parexel is seeking a highly experienced Regulatory Affairs Director to lead our clinical trial regulatory submissions team. As a key member of our team, you will be responsible for managing global trials, ensuring compliance with regulatory requirements, and providing guidance to project teams.

Key Responsibilities

  • Clinical Trial Regulatory Submissions: Over 15 years of experience in clinical trial regulatory submissions, with a strong understanding of regulatory requirements and guidelines.
  • Regulatory Leadership: Proven 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 reviews, 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).

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