北京招聘

Since opening in 2007, 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. This is a great time to join PPD China. Currently PPD is recruiting for Senior Regulatory Affairs Specialist to join us.

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 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.

Summarized Purpose:

Manages a team of staff and junior managers within the department and provides innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization.

Essential Functions and Other Job Information:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients; manages the coordination of and ensures quality performance for key client projects. Manages project budgeting/ forecasting. Leads and participates in project meetings.
• Manages the finalization and review of regulatory documents and submissions.
• Ensures identification of 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 staff with up-to-date legislation and guidance as it becomes available.
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Creates and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. Participates in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics and other key performance indicators.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• 2+ years of management responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Strong English language communication and negotiation skills, as well as local language where applicable, both oral and written
• In-depth understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management
• Broad understanding of ICH and other global regulatory guidelines
• In-depth knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC, publishing, etc.
• Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
• Capable of supervising, evaluating, and mentoring departmental personnel
• Capable of delegating tasks and facilitating the completion of assignments
• Capable of driving innovation in developing new ideas related to process improvements
• Advanced organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
• Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
• Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
• Capable of independently learning new technologies

Our offer: PPD is a place where you can grow.

We want enthusiastic, energetic and creative regulatory staff to join us.

Our corporate and regulatory training and development programme, tailored to match your skills and needs, will put you on a track where you will:

• quickly be assigned to one or more ongoing regulatory projects
• have opportunity to positively contribute early in your time with PPD.
• get internal exposure to subject matter experts who can enhance your learning and development
• according to performance, have opportunity to work on wider range of projects and/or take specific responsibilities for specific elements of a project, including client interface
• be able to grow to reach the point where you are considered to lead/manage regulatory projects in PPD.

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 ************.