Director/Sr. Director of Global Regulatory Affairs Lead
15000 CNY~20000 CNY/Per month
Full-time
More than 10 years
Refresh at 3 months ago
251 Views
49 Apply
Beijing
Share
Job responsibilities
Leads the GRT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.
Job Requirements
Qualification Requirements:
Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.
Other Information/Additional Preferences:
Travel expected (10%)
Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan
Previous regulatory or leadership assignments across multiple countries
Industry-related experience in regulatory affairs and/or drug development experience for 10 years
Direct experience in clinical and CMC regulatory sciences
Experience in applicable therapeutic area (Oncology)
Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
Strong written, spoken and presentation communication
Demonstrated negotiation and influence skills
Demonstrated attention to detail
Required Experience cont'd: Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
Serve as a mentor for GRA personnel.
Similar jobs
Search for your dream jobs
Job category
City or country
Company info
Also view
Music Content Operator
GEOR Global Recruitment (Shenzhen) Ltd.
50000 THB~70000 THB/Per month
Full-time
Thailand
Save job
Headhunting
Refresh at 2 days ago
Investment Manager
Hong Kong Land Industrial Group Co., Ltd.
70000 CNY~120000 CNY/Per month
Remote
Hongkong
Save job
0 Views
0 Apply
Refresh at 3 days ago
Overseas After-Sales Manager
Bole Intelligence(B)
15000 CNY~20000 CNY/Per month
Full-time
Shenzhen
Save job
0 Views
0 Apply
Refresh at 18 days ago
Overseas ESG Management
Heaven Gifts
15000 CNY~20000 CNY/Per month
Full-time
Shenzhen
Save job
0 Views
0 Apply
Refresh at 18 days ago
Art Teacher(Part-time)
Shanghai Xiyou Culture Communication Co., Ltd.
15000 CNY~20000 CNY/Per month
Part-time
Shanghai
Save job
0 Views
0 Apply
Refresh at 19 days ago
AP Teacher
SHENZHEN AMERICAN INTERNATIONAL SCHOOL
15000 CNY~20000 CNY/Per month
Full-time
Shenzhen
Save job
0 Views
0 Apply
Refresh at 19 days ago
Foreign STEAM Teacher
SHENZHEN AMERICAN INTERNATIONAL SCHOOL
15000 CNY~20000 CNY/Per month
Full-time
Shenzhen
Save job
0 Views
0 Apply
Refresh at 19 days ago
R&D Laboratory Specialist
Papkot
15000 CNY~20000 CNY/Per month
Full-time
Shenzhen
Save job
0 Views
0 Apply
Refresh at 19 days ago
After-sales Service
15000 CNY~20000 CNY/Per month
Full-time
Beijing
Save job
0 Views
0 Apply
Refresh at 19 days ago
Native Part-time English Teacher needed
Shanghai Plus Ivy Education Company
15000 CNY~20000 CNY/Per month
Part-time
Shanghai
Save job
0 Views
0 Apply
Refresh at 19 days ago