Associate Regulatory Affairs Director
上海唯讯人力资源有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2012-08-08
- 工作地点：北京
- 招聘人数：1
- 工作经验：十年以上
- 学历要求：硕士
- 语言要求：英语精通
- 职位类别：药品注册
职位描述
Key Task Areas:
? Assisting Regulatory Affairs Director in Regulatory and Business Planning
? Developing regulatory strategy for responsible TA products
? Regulatory project management
? Recruiting, supervising, training and developing team members.
? Contribute to local GRP construction
Responsibilities:
? Provide regulatory leadership, expertise & value in strategic planning, and get alignment from TA core team task force to accelerate the submission, approval & launch of responsible TA new pipeline (new molecules, indications & line extensions) to improve patient outcomes in China
? Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence.
? Ensure product registration and perform regulatory affair activities under company's policies and standard operating procedures, and other applicable laws and regulations.
? Communicate with regulatory agencies/institutes (e.g., SFDA, CDE, NICPBP, coast drug control institute) and company internal departments on product registration issues.
? Monitor and evaluate the new regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of RAD.
? Participate in the construction of GRP in RA team.
? Cross-functional
? Provide input and advice on the new product launch plan in terms of regulatory requirement.
? Collaborate with related functions to ensure market supply sufficient, artwork and labeling comply with agency requirement and marketing promotion needs.
? Perform ad hoc projects or assignments.
Qualification:
? At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences
? At least 10-years experience in drug regulatory affairs with at least 5-year supervisor experience in global leading pharmaceutical company
? Good command of English writing, speaking and listening skill
? Self-motivated and Innovative
? Assisting Regulatory Affairs Director in Regulatory and Business Planning
? Developing regulatory strategy for responsible TA products
? Regulatory project management
? Recruiting, supervising, training and developing team members.
? Contribute to local GRP construction
Responsibilities:
? Provide regulatory leadership, expertise & value in strategic planning, and get alignment from TA core team task force to accelerate the submission, approval & launch of responsible TA new pipeline (new molecules, indications & line extensions) to improve patient outcomes in China
? Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence.
? Ensure product registration and perform regulatory affair activities under company's policies and standard operating procedures, and other applicable laws and regulations.
? Communicate with regulatory agencies/institutes (e.g., SFDA, CDE, NICPBP, coast drug control institute) and company internal departments on product registration issues.
? Monitor and evaluate the new regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of RAD.
? Participate in the construction of GRP in RA team.
? Cross-functional
? Provide input and advice on the new product launch plan in terms of regulatory requirement.
? Collaborate with related functions to ensure market supply sufficient, artwork and labeling comply with agency requirement and marketing promotion needs.
? Perform ad hoc projects or assignments.
Qualification:
? At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences
? At least 10-years experience in drug regulatory affairs with at least 5-year supervisor experience in global leading pharmaceutical company
? Good command of English writing, speaking and listening skill
? Self-motivated and Innovative
公司介绍
1. Company Profile
Combined by a group of Human Resource professionals who have sound experiences in top global corporations. Vision HR positions itself as the human resources solution provider for all human resource needs. We build your success in business by building your workforce. We will work with your different operational divisions as well as with the HR department to better leverage pools of talent and add value to your organization.
2．Service Philosophy
Vision HR guarantees to provide a specialized and efficient service through good communication to clients, multi-understanding of the job description and the candidate's information, and flawless operation of the local labor law issues.
The key is find right person for right position is our service philosophy of being successful. No matter it is in the past, now, or in future, all of us will offer service of giving customer's satisfied service.
3. Our Goal
To be a trusted advisor to our clients
Combined by a group of Human Resource professionals who have sound experiences in top global corporations. Vision HR positions itself as the human resources solution provider for all human resource needs. We build your success in business by building your workforce. We will work with your different operational divisions as well as with the HR department to better leverage pools of talent and add value to your organization.
2．Service Philosophy
Vision HR guarantees to provide a specialized and efficient service through good communication to clients, multi-understanding of the job description and the candidate's information, and flawless operation of the local labor law issues.
The key is find right person for right position is our service philosophy of being successful. No matter it is in the past, now, or in future, all of us will offer service of giving customer's satisfied service.
3. Our Goal
To be a trusted advisor to our clients