上海招聘

Job Summary ：

– Be accountable for implementing regulatory filing strategy to obtain the regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product group

– Support line-manager on the regulatory strategy assessment and provide inputs

Job required competency ：

1. Regulatory knowledge -Understands regulations, local guidelines & evolving environment and applies to the work -Understands the role and the practice of regulatory activities -Actively pursues regulatory knowledge enhancement. -Makes valuable contributions to the development of regulatory practices, procedures and standards

2. Drug Development and Business Knowledge -Understands key activities in drug development and commercialization, the role of different function areas and incorporates into regulatory activities -Understands Roche business fundamentals and incorporates into decision-making -Understands pre-clinical, clinical and manufacturing drug development knowledge and applies to regulatory activities -Develops internal and external network to obtain information and intelligence

3. Regulatory Strategy and Policy -Understands business process and involves in regulatory strategies and policies development

4. Stakeholder management -Understands the structure, key roles and responsibilities of internal and external customers/stakeholders -Understands stakeholders needs and communicates timely and effectively -Builds relationships internally and externally, and applies effective stakeholder management practices.

5. Operational excellence -Meets timelines for completing regulatory filing/approval and other activities with desired quality -Collaborates with internal stakeholders to ensure smooth product supply -Ensures daily work in compliance with SOP and regulatory requirements -Collects and analyzes regulatory intelligence

6. Change management -Accepts change as positive -Adapts to changing conditions -Departs from accepted group norms of thinking and behaving when necessary

7. Leadership competency -Addresses and resolves conflict by creating an atmosphere of openness and trust -Works effectively with other people over whom he or she has no direct authority -Be good at promoting an idea or vision

RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services.


RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us.


Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS!


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