Regulatory Affairs Officer

Job description

·  Job facts

Job Summary岗位简介
– 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 岗位所需胜任力
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.
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
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
-Starts to build 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

Basic Qualification and Experience 基本能力与经验
Education/Qualifications
B.S. or above in Pharmacy, Medical, Biology or related field
Relevant working experience:
* > 4 years' experience in MNC Pharma company, at least 6 years in Regulatory
* independent working
* experience in drug/biologic manufacturing is a plus
Language and PC Skills:
Chinese (mother-tone level) and English (proficiency level)
Computer skill: word, excel, power-point

·  Who we are

在罗氏，来自100个国家的98，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。

罗氏提供平等的职业发展机会。