北京招聘

岗位职责：

1.  Develop andimplement registration plan for new products in China within relevanttherapeutic areas.

2. Manage registrationsubmissions for new products registration and clinical trial applications.

3. Manage registrationsubmissions for license renewal and variations of marketed products and ensureoptimal regulatory support to product lifecycle management for businessobjectives.

4. Ensure successfulimplementation of Regulatory Affairs and high quality of filing dossier.

5. Establish andmaintain direct contact with European / regional regulatory team forinformation sharing and ensuring timely support.

6. Undertakeinteractions and negotiations with Regulatory Authorities to optimize regulatoryapprovals.

7. Closely follow up regulationchanges and analyze/predict its impact on company registration strategies.

8. Keep RA Headinformed for the progress of regulatory projects, identify and discuss criticalissues and potential solutions before implementation.

9. Contribute to companysystems development, support China RA team to develop or enhance regulatoryrelated SOPs, management systems, working procedures, etc. to improve teamoperational efficiency.

1. Profound knowledgeof pharmaceutical business, worldwide drug development and regulatoryprocesses, expertise of international and national regulatory guidelines.

2. Ability toeffectively manage interactions with internal and external stakeholders forensuring optimal cooperation.

3. Understanding ofmarket access needs and implementation of appropriate measures for health carepurposes.

4.Strong interpersonalskills and ability to interface effectively with company local relevantfunctions and global regulatory team.

5. Ability toanticipate and facilitate issue resolution to meet local registrationrequirements.

6.  High leadershipskills with both practical and short/long term strategic vision; ability tobuild relationships; strong team leader as well as team player.

7.  Demonstrates andencourages ownership and responsibility; drive/motivation - has a “can-do”attitude and is committed to delivering high quality results and strives forcontinuous improvement.

8.A good blend ofstrategic and analytical thinking; innovative personality; able to see thebigger picture. 

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我们拥有一支年轻、高效、专业的高品质团队，团队核心成员均来自阿里巴巴、腾讯、滴滴出行等知名大厂，多为80后、90后；公司高度重视人力资源的培养与挖掘，“鼓励创新”、“创业精神”的用人理念，拥有完善的人才培养体系及晋升机制，与员工一起成长，未来可期。"