工作职责：

Position Overview:
Reporting to the Director of Regulatory Affair in China, the successful candidate will be responsible for timely submission of in-line product variations and new product filings at different stages by close collaboration with other functions. He or she will also be responsible for regulatory intelligence, system maintenance and acts as representatives in trade associations.

Primary Responsibilities:
·Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable - to the China MA, designing an appropriate local ad-hoc action plan, as necessary.
·Ensures maintenance of authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
·Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
· Participates in task forces of Agency/Pharmaceutical industry for new regulations and implementation of new ones.
· Maintains a positive relationship with internal and external regulatory contacts. Acts as essential point of local regulatory agency contact for the company in case of any urgent regulatory agency requests. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
· Ensures that marketing authorizations are maintained in compliance with related regulatory areas.
· Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package, Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to company and local standards. Keeps informed with Manufacturing Organization to ensure that Prescribing Information is implemented within the correct timeframes for compliance.
· Ensures accuracy of artwork mockup.
· Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
· Ensures that files and archives related to Regulatory are kept updated and complete.
· Provides regulatory representation for GCP and PV inspection teams and ensure that the regulatory components are addressed.

任职资格：

Skills:
Primary skills include but are not limited to
1. Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals; possesses advanced leadership skills.
2. Communication Skills: Demonstrates advanced communications skills to convey and receive information in English and local language. Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills and ability to adapt presentations to various audiences.
3. Problem Solving: Demonstrates expert level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
4. Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally within MRL/MMD/GHH that improve quality and /or add value to the business.
5. Project Management: Demonstrates expert ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
6. Decision Making: Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
7. Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.
8. Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure the functional areas within the company are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

Experience:
1. A minimum of 7 years of experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies.
2. The candidate must be familiar with China legislation procedures and guidelines governing pharmaceutical products. The candidate would be expected to have had at least 3 years of experience in a regulatory affairs position.

Education:
MS degree in pharmacy or other life science is required.