Director, Regulatory

Director, Regulatory

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

The Director Regulatory Affairs will provide leadership of teams responsible for regulatory submissions worldwide. The Director Regulatory Affairs will provide regulatory strategy and support for all regulatory and ethics submission in relation to Clinical Trials and drug development including Health Authority interaction, attending meetings, and provision of strategic regulatory support to other departments, project teams, and committees. The Director Regulatory Affairs will support the development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.

Essential functions of the job include but are not limited to :

• Provide strategic, technical, and regulatory guidance to clients and team members in the area of clinical development of human medicinal products and drug development life cycle
• Establish operational objectives and assignments for assigned team members
• Track and report regulatory function metrics and key performance indicators
• Oversee, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA / IND, annual reports, routine amendments, scientific advice / regulatory authority meetings, orphan designations, paediatric planning, and expedited pathways
• As needed, review documents intended for submission to the Regulatory Authorities and / or Ethics Committees to ensure compliance with regulatory standards
• Select, train, develop, coach and manage the performance of Regulatory Managers, ensuring the sharing of best practices across the team
• Oversee resource allocation and utilization of Regulatory Managers
• As needed, represent Global Regulatory Affairs at project team meetings with both external and internal customers and manage / oversee regulatory workflow between departments
• Provide oversight to filing and study teams regarding regulations / guidelines and company SOPs to ensure successful and high-quality regulatory applications
• Ensure budgets and plans meet corporate requirements
• Provide ICH / GCP / Regulation guidance, advice and training to internal and external clients
• Participate in developing, implementing, and maintaining the corporate quality initiatives across business units within Clinical Solutions / Precision for Medicine
• Implement regulatory tools to support the department
• Assist in developing, modifying and executing company policies that affect Regulatory Affairs and may impact other departments
• Support QA audits and / or assign applicable team members to participate in audits
• Establishes and maintains a high level of technical knowledge in the area of product development and international regulatory affairs. Interprets emerging regulatory requirements and collaborates in impact assessment and implementation
• Supports Business Development in generation of customer focused, well-presented regulatory proposal content and budgets, partnering with other functional areas as required to define bid content, strategy, scope of work

Qualifications :

Preferred :

Other Required :

Competencies :

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

About Precision for Medicine :

Precision for Medicine is a precision medicine Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.