长春招聘

Summary of Job Responsibilities:

1.      Lead regulatory strategy development and submission activities for assigned R&D projects in one TA

    

2.      Represent RA and provide regulatory strategy input for China compound teams; execute CTA & NDA/BLA filings; lead CDE consultation preparation activities and meeting minute’s preparation.

    

3.      Ensure timely Regulatory filings and response to HA queries for R&D portfolios

    

4.      Provide mentoring and coaching to junior staff members

    

5.      Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization

Dimensions of Job:

1. Regulatory strategic support for assigned R&D projects including registration pathway and acceleration strategy 

2. Regulatory strategy input to R&D functions and China compound teams 

3. Liaise with Regulatory agency 

4. Regulatory process development & resource planning    

Principal Accountabilities of Job:

1.Collaborate with global, regional and local product teams to develop and implement registration plan and regulatory strategy.

2.Oversees regulatory activities & review critical submissions for assigned R&D projects.

3.Ensure timely Regulatory submission and team response efforts to HA request.

4.Lead cross-functional preparation for CDE consultation meetings.

5.Interact with HA review divisions.

6.Actively lead or involve in review and revision of regulations, guidelines.

7.Develop internal regulatory process for effective operation.

8.Credo based behavior with regulatory compliance excellence.         

Qualifications & Competencies: 

1.    Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred. 

 2.    Minimum of 5-8 years regulatory affair experience in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred. 

 3.    Strong oral & written communication skill; Strong leadership capability and ability to work under pressure. 

 4.    In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration. 

 5.    Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization. 

 6.    Proficiency in verbal and written English; good computer skill, good presentation skill.             

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务覆盖上海、北京、广州、深圳等逾20座直营城市。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有70年服务经验。凭借万宝盛华全球的声誉及行业经验，万宝盛华大中华深耕本土20余年。2015年，万宝盛华大中华战略联盟中信产业基金，总部落地上海，服务网络覆盖两岸三地130余城市逾两万家企业。我们始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、人才管理及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。