（Sr.) Regulatory Affairs

该职位来源于猎聘 Key Responsibilities

• Regulatory Strategy & Lifecycle Management
• Develop and execute global regulatory strategies for biologics (IND, BLA, NDA, MAA, NMPA filings) aligned with business and R&D timelines
• Monitor ICH/FDA/EMA/NMPA guidelines, lead gap analysis, risk assessment and feasibility studies to resolve regulatory hurdles
• Senior Level: Lead the registration team, build long-term portfolio roadmap, and drive cross-functional decision-making
• Dossier Preparation & Submission
• Lead end-to-end eCTD dossier preparation, review and submission for global filings, variations and post-approval supplements
• Coordinate cross-functional teams to ensure data accuracy, completeness and on-time submission compliance
• Senior Level: Oversee multiple projects, allocate resources efficiently and mentor junior team members
• Regulatory Authority Engagement
• Act as the primary regulatory contact for FDA, EMA, NMPA and other global agencies
• Lead pre-submission meetings, RFI responses, deficiency resolution and regulatory inspection support
• Track regulatory updates and communicate implications to internal stakeholders
• Compliance & Governance
• Ensure full compliance with global regulatory laws, GRP and internal policies, maintain complete regulatory documentation
• Support regulatory inspections and drive timely closure of findings.

Qualifications & Requirements Education

• Master’s degree in Pharmacy, Biology, Biotechnology, Biochemistry or related scientific disciplines Professional Experience
• Manager: 5-7 years of biologics regulatory affairs experience in pharma/biotech, proven expertise in IND/BLA/NDA/MAA/NMPA filings
• Senior Manager: 8-10+ years of relevant experience, 3+ years of team management experience, track record of successful global biologics approvals
• Mandatory: Hands-on eCTD dossier submission and direct regulatory authority interaction experience
• Preferred: Background in mAbs, ADCs, recombinant proteins or cell/gene therapies; post-approval lifecycle management experience Core Competencies
• Deep expertise in ICH/FDA/EMA/NMPA regulations and biologics registration processes
• Excellent project management, cross-functional leadership and prioritization skills
• Exceptional written & verbal communication skills for complex regulatory dialogue Strong attention to detail, compliance mindset and problem-solving capabilities