China RA manager

Responsibilities

• 1、Regulatory Submission Preparation & Execution
• Lead the preparation, review, and compilation of high-quality regulatory dossiers (e.g., CTD/eCTD format) for product registrations, variations, renewals, and other regulatory filings to NMPA and other global health authorities.
• Ensure accuracy, consistency, and compliance of submission documents with regional guidelines, company SOPs, and global regulatory standards.
• Coordinate with cross-functional teams (R&D, CMC, Clinical, Quality, Medical Affairs) to collect, validate, and consolidate technical and clinical data for regulatory submissions.
• Manage submission timelines, track deliverables, and resolve document-related issues to ensure on-time filing.
• 2、Regulatory Compliance & Lifecycle Management
• Monitor and maintain regulatory compliance of registered products, including tracking license renewals, post-approval commitments, and periodic safety update reports (PSURs)/periodic benefit-risk evaluation reports (PBRERs).
• Support the management of product variations (minor/major) and post-approval changes, including preparing relevant documentation and liaising with regulatory authorities for review and approval.
• Keep abreast of the latest regulatory updates, guidelines, and policy changes from NMPA, FDA, EMA, and other global agencies; conduct impact assessments and communicate key changes to the team and cross-functional stakeholders.
• 3、Regulatory Communication & Liaison
• Act as a key point of contact for regulatory authorities (e.g., NMPA) for routine inquiries, document supplements, and review feedback during the submission and approval process.
• Prepare and respond to regulatory information requests (IRs) and deficiency letters in a timely and accurate manner, in collaboration with technical teams.
• Support the organization of regulatory meetings (e.g., pre-submission meetings, inspection preparations) and prepare meeting materials, minutes, and follow-up action plans.
• 4、Document & Data Management
• Maintain accurate and up-to-date regulatory document repositories (e.g., eCTD databases, regulatory information management systems) and ensure proper version control and archiving of all regulatory records.
• Compile and report regulatory metrics (e.g., submission timelines, approval status, compliance milestones) to the RA management team and global stakeholders.
• Support the development and update of company regulatory SOPs, templates, and guidelines to align with global and regional requirements.
• 5、Cross-functional Collaboration & Global Alignment
• Collaborate with global RA teams to ensure consistency in regulatory strategies, submission approaches, and documentation across regions.
• Work closely with R&D, CMC, Clinical Operations, and Quality teams to address regulatory requirements throughout the product development and commercial lifecycle.
• Provide regulatory guidance and support to internal teams on day-to-day regulatory queries and project-specific requirements.

Requirements

• Bachelor's/ Master's degree in Pharmacy , Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or a related life science field; advanced degrees are a plus.
• above 5 years of relevant regulatory affairs experience in the pharmaceutical/biotechnology industry.
• Experience with CTD/eCTD dossier preparation, regulatory submissions, and post-approval lifecycle management is highly desirable.
• Familiarity with pharmaceutical product development (CMC, clinical, quality) is a plus.
• Regulatory Knowledge
• Working knowledge of NMPA regulations and guidelines ; basic understanding of FDA/EMA/PMDA regulatory requirements is an advantage.
• Familiarity with regulatory document formats (CTD/eCTD), PSUR/PBRER preparation, and post-approval variation processes.
• Fluent in Mandarin and English, oral and written
• Expert MS Office skills
• Excellent organizational, time management and interpersonal skills in a global environment.
• Ability to work successfully in a complex matrix organization.
• Proven ability to work effectively both independently and in a team.
• The expertise, determination and courage to resolve or escalate issues as appropriate.
• About CSL Behring
• CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesavi

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