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Director of Regulatory Operations
hace 2 meses
Job Title: Associate Director, Regulatory Affairs
Company: Innovaderm Research
Location: Remote
Job Type: Full-time
Industry: Pharmaceutical, Biotechnology, CRO
Job Description:
Overview:
The Associate Director, Regulatory Affairs will be responsible for managing and overseeing the services provided by the Regulatory Affairs group in the assigned regions, ensuring they are conducted according to Innovaderm's standard operating procedures, applicable regulations, good clinical practices, and the Sponsor's satisfaction.
Responsibilities:
- Providing leadership on regulatory activities that lead to global start-up of clinical trials.
- Planning and assigning work, overseeing the performance of direct reports, and performing annual reviews.
- Addressing employee relation issues and escalating issues as necessary.
- Overseeing Regulatory Affairs activities of direct reports to ensure quality deliverables on time, within budget, and in compliance with SOPs, industry standards, regulations, and study-specific requirements.
- Managing performance, establishing clear objectives and performance indicators, conducting formal performance reviews, and developing direct reports.
- Planning regional resources by forecasting project needs and overseeing recruitment efforts.
- Ensuring adequate regional training of the team and alignment of practices across the team.
- Serving as subject matter expert (SME) in regulatory within the department and assisting with submission strategies.
- Serving as a senior point of contact for project teams on regulatory activities.
- Supporting strategic business expansion activities.
- Reviewing documents and submissions prepared by the regulatory team.
- Leading departmental quality and process improvement initiatives.
- Participating in request for proposals and outlining regulatory strategies.
- Ensuring adequate monitoring of out-of-scope work by direct reports.
- Overseeing implementation of systems related to departmental activities.
- Overseeing vendors and subcontractors supporting the department.
- Writing, reviewing, and updating related SOPs, tools, and working instructions.
- Centralizing global changing regulatory requirements and maintaining regulatory intelligence databases.
- Acting as point of contact for client audits and regulatory agency inspections.
- Participating in function and/or corporate initiatives and special project assignments.
- Maintaining familiarity with relevant current industry practices and regulatory requirements.
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.