2024-01-06
191次
Director/Sr. Director, Regulatory Affairs
18000-25000元/月
工作性质全职
职位类别生物工程/生物制药
招聘人数若干人
学历要求硕士
工作经验不限
性别要求不限
年龄要求不限
招聘区域
不限
招聘部门不限
工作地点亚洲/不限地区
职位动态
0%
近两周该职位的简历处理率
简历处理率0天
简历平均处理时长
2024-01-06
企业最近登录时间
职位描述
Key Responsibilities
Responsible to proactively develop innovative, robust regulatory strategies in Greater China and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development in oncology, Immunology and Infectious diseases
Ensure timely and high quality submissions
Provide guidance and oversight for health authority interactions/meetings
Provide input to global regulatory strategies for each project within the Therapeutic area(s)
Direct the team efforts required for the submission of INDs, BLAs, sBLAs as well as related supplements and annual reports
Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
Regulatory representative on due diligence activities for external development candidates
Coach and mentor junior members in their roles on global project teams and as the leader of regional regulatory team
Have an understanding of the competitive environment of the various indications in oncology, Immunology and Infectious diseases
Provides regular and timely updates to senior management on the status of all pending applications and planned submissions as necessary
Qualifications
Minimum M.S. degree in life/health sciences required
A minimum of 10+ years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Authorization Applications
In depth knowledge of China regulatory guidelines and knowledge of global regulatory requirements
Ability to work independently within project teams, committees, etc. to attain group goals
Demonstrate excellent communication skills
Responsible to proactively develop innovative, robust regulatory strategies in Greater China and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development in oncology, Immunology and Infectious diseases
Ensure timely and high quality submissions
Provide guidance and oversight for health authority interactions/meetings
Provide input to global regulatory strategies for each project within the Therapeutic area(s)
Direct the team efforts required for the submission of INDs, BLAs, sBLAs as well as related supplements and annual reports
Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
Regulatory representative on due diligence activities for external development candidates
Coach and mentor junior members in their roles on global project teams and as the leader of regional regulatory team
Have an understanding of the competitive environment of the various indications in oncology, Immunology and Infectious diseases
Provides regular and timely updates to senior management on the status of all pending applications and planned submissions as necessary
Qualifications
Minimum M.S. degree in life/health sciences required
A minimum of 10+ years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Authorization Applications
In depth knowledge of China regulatory guidelines and knowledge of global regulatory requirements
Ability to work independently within project teams, committees, etc. to attain group goals
Demonstrate excellent communication skills
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