Regulatory Affairs Manager
hace 2 días
Job Summary:
We are seeking an experienced Manager, Regulatory Affairs to join our team at Innovaderm Research. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with applicable regulations and good clinical practices.
Key Responsibilities:
- Provide leadership on regulatory activities that lead to global startup of clinical trials
- Plan and assign work, oversee the performance of direct reports, and conduct annual reviews
- Address employee relation issues and escalate concerns as needed
- Manage a team of Regulatory Affairs employees, including performance management and talent development
- Ensure adequate resources to sustain regional activities of the regulatory affairs group
- Manage resource selection and onboarding processes for new employees
- Develop regulatory affairs practices, improvement initiatives, tools, processes, and training material to support departmental activities
- Provide regulatory submissions strategic advice and act as a point of contact for Sponsors and subcontractors/project teams
- Oversee resource assignments and participate in the preparation, review, submission, maintenance, and tracking of regulatory authority and IRB/IEC submissions
- Ensure adequate review of activities performed outside of the company by subcontractors to ensure high quality standards before submission
- Support project teams with oversight of submissions in global regions, such as Asia Pacific
- Prepare and/or review master and country-specific Informed Consent form documents
- Assist with the oversight of vendors supporting the department
- Oversee regulatory review of essential documents to authorize shipment of investigational product to clinical sites
- Oversee labelling review of clinical trial drug supplies to ensure conformity with regional regulations requirements
- Oversee the activities associated with clinical SAE reporting (tracking and submission to regulatory authorities, IRB/IEC, and Investigators)
- Participate in the preparation and review of SOPs and associated tools
- Ensure centralization of start-up global regulatory information and maintenance of the regulatory intelligence database
- Participate in regulatory watch activities
- Participate in bid defense meetings, project Kick-off meetings, audits, inspections, and other project-related meetings
- Contribute to the development of project budgets for alignment with the scope of work and to the development of business development proposals
- Participate in function and/or corporate initiatives and special project assignments
- Maintain familiarity with relevant current industry practices and regulatory requirements and guidelines
Requirements:
- Bachelor's degree (or equivalent) in life sciences or scientific discipline
- At least 5 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry
- Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packages
- Excellent knowledge of applicable regional/national country regulatory and IRB/IEC guidelines and regulations
- Experience in team leadership; line management experience an asset
- Excellent knowledge of Microsoft Office suite
- Fluent in English with excellent oral and written communication skills; additional languages represent an asset
- Ability to organize departmental work, prioritize different assignments, and work under pressure
- Attention to detail and accuracy in work
- Versatile and comfortable in a multitasking environment
- Respect established timelines, expectations, priorities, and objectives
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
About Innovaderm Research:
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment and attractive advancement opportunities. Our values are collaboration, innovation, reliability, and responsiveness.
What We Offer:
- Flexible work schedule
- Permanent full-time position
- Company benefits package
- Ongoing learning and development
How to Apply:
Please submit your application, including your resume and cover letter, to [insert contact information]. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
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