Remote Regulatory CMC Lead — Small Molecule + Veeva RIM

Syneos Health, Inc.; Ontario (CA); Remote; USD 84,000 - 126,000; Full time

Job summary

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant for small molecule programs and Veeva RIM. The role focuses on leading regulatory activities across multiple regions with a strong emphasis on INDs, product registrations, and post-approval maintenance.

Remote, ON, Canada-based opportunities are available for qualified candidates. The incumbent will oversee project teams, contribute to strategy, and provide regulatory guidance to colleagues and clients, while coordinating

Qualifications

• Experience planning regulatory submissions for assigned regions.
• Ability to manage multi-disciplinary teams and timelines.
• Strong guidance on INDs, registrations, and post-approval activities.

Responsibilities

• Contributes to planning regulatory submissions in assigned region/country/project.
• Responsible for day to day management of project teams and projects.
• Line management responsibilities for staff members and related activities.
• Acts as a representative of regulatory department with other departments.
• Supports business development and proposal development.
• Monitors project budgets, invoicing, and utilization.
• Leads client and regulatory agency meetings and provides regulatory advice.

Skills

Regulatory submissions

Project management

Team leadership

Veeva RIM

Tools

Veeva RIM

Job description

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant for small molecule programs and Veeva RIM. The role focuses on leading regulatory activities across multiple regions with a strong emphasis on INDs, product registrations, and post-approval maintenance.

Remote, ON, Canada-based opportunities are available for qualified candidates. The incumbent will oversee project teams, contribute to strategy, and provide regulatory guidance to colleagues and clients, while coordinating