Line Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Canada.

📋 Description

• Manages the Ethics Committee (EC), Regulatory Authority (RA), and other submissions to ensure compliance and timely processing.

• Provides guidance for designated projects and regulatory assistance to project teams.

• Prepares and reviews essential packages and country-specific packages for RA submission.

• Serves as the primary contact for preparing, managing, and tracking IRB/IEC submissions.

• Conducts peer reviews of documents prepared by colleagues within the regulatory team.

• Assesses regulatory documents created by subcontractors for quality assurance prior to submission.

• Acts as the liaison for regulatory bodies and local teams concerning submissions.

• Reviews and drafts study-specific regulatory documents and forms.

• Oversees translations with vendors and manages the submission of SUSARs.

• Participates in meetings, audits, and project-related activities.

• Ensures the completeness of the Trial Master File (TMF) through timely document submissions.

• Provides leadership and supervision to direct reports, including setting goals and mentoring.

• Engages in process improvement initiatives and other responsibilities as needed.

⛳️ Requirements

• Education: Bachelor’s degree (or equivalent) in a scientific field.

• Experience: 3-5 years in clinical regulatory affairs within the pharmaceutical, biotechnology, and/or CRO sectors; experience in preparing and submitting IRB/IEC packages and/or Clinical Trial Applications.

• Comprehensive understanding of relevant regional/national regulatory guidelines and IRB/IEC regulations.

• Familiarity with CTIS on both local and regional levels.

• Experience in functional staff management is advantageous.

• Capability to nurture the skills of others and inspire team members.

• Exceptional communication abilities.

• Proficient in the Microsoft Office suite.

• Fluency in English with strong oral and written communication skills is essential; knowledge of additional languages is a plus.

• Strong attention to detail and precision in work.

• Ability to organize personal workload, prioritize various tasks, and perform well under pressure.

• Adaptable and comfortable in a multitasking environment.

• Adheres to established timelines, expectations, priorities, and objectives.

• Good understanding of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA) regulations, and Regulation (EU) No 536/2014.

🏝️ Benefits

• Permanent full-time position

• Flexible schedule

• Vacation

• Home-based position

• Ongoing learning and development