Senior Director, Regulatory Affairs
About the role
This vacancy has now expired. Please see similar roles below...
Location: Dundas, Ontario or Remote North America
Type: Full time, permanent
- Effectively oversee the preparation of regulatory submission documents in adherence with applicable Regulations and Directives for submission to government agencies (focus on the US).
- Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project team. Building positive working relationships with clients and government agency contacts.
- Review and/or create study reports, clinical protocols, safety and efficacy reports for accuracy and compliance to regulations. Review of draft submissions for regulatory content and the editorial viewpoint.
- Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Lead and participate in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and government agencies. Build positive working relationships with clients and government agency contacts.
- Interact with potential clients to develop new business and create win-win agreements.
- Identify project issues and develop alternate strategies for presentation to client. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
- Participate in or conduct quote preparation and new project / client consultations.
- Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies.
- Present industry related training seminars or workshops at industry conferences.
- Participate in the planning and execution of the strategic direction for the US business.
- Significant experience of pharmaceutical / biologics development in the US regulatory environment, including leadership and/or senior consulting experience.
- Expert knowledge and understanding of the development process for pharmaceutical and Biological products including: CMC, non-Clinical and Clinical
- Working knowledge of venture capital and credit markets and their role in drug development
- Strong knowledge of a variety of computer programs including MS Office, Adobe Acrobat, and eCTD compiling software, EDMS systems
- Displays full knowledge of protocol, regulatory requirements, and company SOPs. Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.
- Advanced degree (M.Sc., Ph.D., M.D., Pharm.D.) in the Biological, Medical, Chemical or Engineering. BSc required.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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