Associate Director, Regulatory Affairs
India, Remote Job ID R0000030010 Category Consulting Date Posted 12/11/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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)
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