广州招聘

PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company.

Since opening in 2003, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform.

This is a great time to join PPD China. Currently PPD is recruiting for Regulator Affairs Manager (individual contributor) to join our Regulatory Affairs department. If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our 775+ regulatory experts in 29 countries contribute the regulatory strategy and knowledge to help our clients navigate the ever-changing China FDA clinical trial regulatory environment—and help get life-changing therapies to patients faster. With our end-to-end solutions, we work to ensure regulatory compliance throughout the product life cycle, while helping to advance global product development.

• Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings.

• Excellent English language (written and oral) communication skills as well as local language where applicable
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Excellent negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Superb understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting

Our offer: As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company. At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position.

Locations we are hiring in are:

• Office based Beijing

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit ************.