Senior Regulatory Affairs Manager
hace 4 semanas
Job Summary
The Senior Regulatory Affairs Manager will oversee the Regulatory Affairs group in assigned regions, ensuring services are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. This role requires leadership on regulatory activities, planning, and assigning work, overseeing direct reports, and performing annual reviews.
Key Responsibilities
- Provide leadership on regulatory activities, including global start-up of clinical trials, planning, and assigning work.
- Oversee the performance of direct reports, including annual reviews, addressing employee relation issues, and escalating concerns.
- 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 and talent conversation meetings.
- Plan regional resources, forecast project needs, and oversee recruitment efforts to ensure adequate resources.
- Ensure adequate regional training and oversee practices to ensure alignment across the team.
- Serve as a subject matter expert in regulatory affairs, assist with submission strategies, and communicate project risks to management.
- Support strategic business expansion activities, including new offerings and geographical regions.
- Review documents and submissions, ensure complete and timely responses to Health Authorities, and perform regulatory project tasks as needed.
- Lead departmental quality and process improvement initiatives, monitor quality issues, and develop proactive solutions.
- Participate in request for proposals and requests for information, outline regulatory strategies, and evaluate project budgets.
- Ensure adequate monitoring of out-of-scope work, 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, ensuring high-quality standards before submission.
- Write, review, and update related SOPs, tools, and working instructions.
- 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.
About Innovaderm
Innovaderm is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment, attractive advancement opportunities, and a company benefits package. As a Senior Regulatory Affairs Manager, you will be eligible for a flexible work schedule, permanent full-time position, and ongoing learning and development.
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