Location：Shanghai/Beijing, Reporting to Head of RA

Responsibilities：

• This position is responsible for leading a high performing regulatory operation function in current RA department. This role will support the Head of Regulatory Affairs in regulatory submissions planning and execution, and work across key function for the delivery of timely and high-quality eCTD submission.
• Lead the review and publish high quality utilizing submission-ready documents using Veeva RIM that adhering to eCTD guideline and internal or regulatory agency’s validation tools to support global filing.
• Work with regulatory lead to manage submission planning and execution globally
• Collect all regulations and guidelines of China and ICH eCTD, response to public comments from CDE on eCTD and data submission. Continuous improvement on China eCTD preparation and work with global operation team for long-term plan.
• Establish and update regulatory related SOPs to fulfill compliance with requirements, and conduct the training accordingly. Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient manner.

Qualifications：

• 10 years experience required in Regulatory Affair, R&D and minimal 5 years experience for regulatory operations including hands on eCTD filing experience to support IND/NDA.
• Good leadership, organization, problem-solving, communication and project management skills to coordinate with cross function for IND/ NDA planning and execution.
• Excellent written and oral communication skills and fluent English both oral and written.
• Ability to manage priorities and workflow, managing multiple projects and meeting deadlines
• Computer Skills: experience in veeva RIM system, Advanced knowledge of Microsoft Word, Adobe Acrobat; knowledge of document authoring templates, and publishing linking and validation tools
• Experience in global pharma and experience in US filing would be a plus.