Regulatory Affairs Director
hace 1 semana
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:- Leadership and Oversight: 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.
- Regulatory Expertise: Serve as a subject matter expert in regulatory affairs within the department and to the organization, assisting with development of submission strategies.
- Project Management: Manage performance, establish clear objectives and performance indicators, conduct formal performance reviews, and develop direct reports.
- Training and Development: Ensure adequate regional training of the team and oversee practices to ensure alignment of practices across the team.
- Client and Stakeholder Management: Serve as a senior point of contact for project teams, client audits, regulatory agency inspections, and serious breach committees.
- Education: Bachelor's degree (or equivalent) in life sciences or scientific discipline.
- Experience: 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.
- Skills: Solid knowledge of review and approval processes of applicable regulatory Health Authorities, excellent communication and interpersonal skills, and ability to assess impact of evolving information and provide guidance.
Innovaderm is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment, attractive advancement opportunities, and a company benefits package. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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