- P.R. China - Shanghai
Our client is a global Life Science Regulatory and Market Access advisory firm assisting biotech and medtech companies to develop innovative HealthTech products. The company supports its clients throughout product development from the design of CMC, non-clinical and clinical development plans and regulatory strategies to their implementation and submissions to regulatory agencies and players. Its expertise encompasses the full spectrum of HealthTech products: drugs, including biologics and cell, gene and tissue therapies, medical devices, including In-Vitro Diagnostics/CDx, combination products, and borderline products, as well as nutraceuticals and cosmeceuticals.
The company has been operating for 20+ years. The Company has few hundred employees, with professionals located across Europe, the USA and APAC. The Company offers rewarding and stimulating career opportunities to its employees due to the diversity of its clients and novelty of their products.
Position: Regulatory Scientist
Reporting line: China General Manager
Missions and Responsibilities:
Regulatory Sciences: Write, review, and assemble high quality regulatory submissions, including but not limited to:
• Preparation of IND modules
• Pre-IND, Pre-NDA briefing documents
• New Drug Applications (NDAs)/Biologic License Applications (BLAs)
• Post-approval changes
• NMPA Interactions and Correspondence-
Project Management: Participate as team member in projects
• As a project team member, execute the prescribed activities for domestic/international client projects, adhering to strategy, timelines, and milestones.
• Project coordination and keeping track of timelines/deliverables using project management tools
• Timely internal and external communications and updates
• Participate in the implementation of regulatory strategies for development and registration of innovative drugs.
• Ensure compliance with regulations and applicable guidelines.
- Knowledge Management
• Perform background research and coordinate scientific, technical, and regulatory surveillance to be performed related to the project.
• Contribute to the knowledge sharing within the organization, assist with BD and marketing related activities
• Stay up to date with local and global regulatory trends and requirements.
- Communicate with external regulatory authorities
- Cooperation with internal regulation team
- Communication with Sponsors
- Communication with clinical operations teams
- Cooperation with other departments including BD and marketing
- Bachelor’s degree and above in a Life Sciences field
- With a minimum of 3 years’ experience in regulatory affairs in pharmaceutical, biotechnology industry
- Demonstrated experience in the establishment of clinical trial applications and supporting approvals of Marketing Applications - Demonstrated experience in interacting with NMPA, knowledge of EU and US regulatory requirement is a plus
- Able to innovate, analyze, and solve problems with minimal supervision
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously - Proficient in English, able to read and communicate in English independently
Suitable candidates will be contacted within a few days.