1. The preparation and execution of the international regulatory affairs departments intelligence strategy.

Led the implementation of regulatory intelligence ensuring strategy is aligned to the business needs;

2. Develop and implement systems for monitoring, analyzing and communicating international regulatory intelligence;

3. Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders;

4. Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information;

5. Synthesize information from global requirements database as well as interaction with local country experts as needed;

6. Experienced in understanding and interpreting regulatory guidelines and documents;

7. Independently prepare registration documents and develop registration plan for oversea markets;

8. Help ensure the quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations, and company standards;

9. Interface with international regulatory teams on regional regulatory strategy and implementation plans;

10. Develop and maintain knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs.

Requirements:

• BA/BS degree and 5+ years of experience in the pharmaceutical industry;

• 5 years in regulatory affairs; international division experience;

• Highly organized and able to work independently to meet deliverable on time and on target;

• Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all level;

• Attentive to details and focused on quality output;

• Regional regulatory experience required; global experience preferred;

• Business awareness and appreciation;

• Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously;

上班地址：北京市