Line Manager, Regulatory Affairs

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🕒 June 2

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

As a CRO (Contract Research Organization) specialized in dermatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site.

📋 Description

• Oversees Ethics Committee (EC), Regulatory Authority (RA), and other submissions to ensure compliance and timely delivery. • Provides leadership for assigned projects and regulatory support to project teams. • Prepares/reviews core packages and country packages for RA submission. • Prepares, manages, and tracks IRB/IEC submissions as primary point of contact. • Peer review of documents prepared by regulatory team colleagues. • Reviews regulatory documents created by subcontractors for quality before submission. • Acts as point of contact for regulatory bodies and local teams regarding submissions. • Reviews and prepares study-specific regulatory documents/forms. • Manages translations with vendors and oversees submission of SUSARs. • Participates in meetings, audits, and project-related activities. • Ensures TMF completeness through timely document submissions. • Provides leadership and management to direct reports, including goal setting and mentoring. • Participates in process improvement initiatives and other assignments as required.

🎯 Requirements

• Education: Bachelor’s degree (or equivalent) in a scientific discipline. • Experience: 3-5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and/or Clinical Trial Applications. • Working knowledge of applicable regional/national country regulatory guidelines, IRB/IEC regulations. • Knowledge of CTIS on a local and regional level. • Functional staff management experience an asset. • Ability to develop skills of others and motivate team members. • Excellent communication skills. • Excellent knowledge of Microsoft Office suite. • Fluency in English with excellent oral and written skills, required; additional languages represent an asset. • Attention to detail and accuracy in work. • Ability to organize own work, prioritize different assignments, and work under pressure. • Versatile and comfortable in a multitasking environment. • Respect established timelines, expectations, priorities, and objectives. • Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014.

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development