Project Manager - Regulatory Affairs

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July 14

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ClinChoice

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Biotechnology • Pharmaceuticals • Healthcare Insurance

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Assist in the planning and tracking of long-term regulatory projects and submission timelines. • Regularly communicate with clients to understand their needs and proactively address them. • Coordinate cross-functional team meetings and facilitate communication to ensure project milestones are met. • Maintain accurate project documentation including project plans, timelines, and status reports. • Drive regulatory updates and assist in assessing their impact on ongoing projects. • Contribute to the development and improvement of regulatory project management processes and tools. • Track project deliverables and resource utilization using appropriate tracking tools to provide direction and support to the project team. • Identify and escalate issues and potential issues in a timely manner to ensure efficient resolution • Provide independent advice on the management of projects based on lessons learned and gained experience. • Contribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team.

🎯 Requirements

• Having experience in managing regulatory operations projects as PM • Strong English communication is a must • Self-driven individual • Flexible to travel for long durations – to Armenia • Mid-level experience 8-10 years should be fine