Regulatory Affairs Director
hace 2 días
Job Summary:
The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices.
Key Responsibilities:- Provide leadership on regulatory activities that lead to global start-up of clinical trials.
- Plan and assign work, oversee the performance of direct reports, and perform annual reviews.
- Address employee relation issues and escalate concerns as necessary.
- Oversee the preparation and submission of Clinical Trial Applications and IRB/IEC packages.
- Ensure quality deliverables on time, within budget, and in compliance with SOPs, industry standards, regulations, and study-specific requirements.
- Manage performance, establish clear objectives, and conduct formal performance reviews.
- Develop direct reports and ensure adequate resources (headcount, experience, role) to sustain activities of the group.
- Ensure adequate regional training of the team and oversee practices to ensure alignment of practices across the team.
- Serve as a subject matter expert in regulatory within the department and to the organization.
- Assist with development of submission strategies and serve as a senior point of contact for project teams.
- Support strategic business expansion activities for new offerings and in new geographical regions.
- Review documents and submissions prepared by the regulatory team and ensure complete and timely response to Health Authorities during application review.
- Lead departmental quality and process improvement initiatives, continuously monitoring, identifying, and reporting quality issues.
- Participate in request for proposals and requests for information for new studies, outlining regulatory strategies and evaluating project budgets.
- Ensure adequate monitoring of out-of-scope work by direct reports and accurate forecasting and recognition of departmental project revenue.
- Oversee implementation of systems related to departmental activities, including change management, documentation of procedures, and training.
- Oversee vendors and subcontractors supporting the department, ensuring adequate review of activities performed outside of the company.
- Write, review, and update related SOPs, tools, and working instructions for assigned regions.
- Ensure centralization of global changing regulatory requirements and maintenance of regulatory intelligence databases.
- Point of contact for client audits, regulatory agency inspections, and serious breach committees.
Innovaderm is a contract research organization (CRO) specialized in dermatology. We have a solid reputation for the quality of our research and services, exceeding the expectations of our clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.
We are committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
We only accept applicants who can legally work in Spain.
Requirements:- Bachelor's degree (or equivalent) in life sciences or scientific discipline.
- At least 8 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry, including 3 years in a management role.
- Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packages.
- Solid knowledge of review and approval processes of applicable regulatory Health Authorities.
- Ability to assess impact of evolving information and provide guidance.
- 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 an asset.
- Excellent interpersonal and intercultural communication skills.
- Advanced ability to have a flexible risk approach and to adapt to changing business needs.
- High ambiguity acceptance.
- Client-focused approach to work and oriented toward problem solving.
- Respect established timelines, expectations, priorities, and objectives.
- Good knowledge of good clinical practices, and applicable Health Canada, Food and Drug Administration (FDA), and local/national regulations/guidelines.
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