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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Beijing, China
Job Description:
Job Summary
This role is responsible for end-to-end regulatory strategy and execution for new asset development and lifecycle management in Hematology/Oncology early development TA in China. This role will lead China regulatory interactions, drive high‑quality submissions and approvals, monitor changes to regulatory requirements and standards, identify and mitigate regulatory risks, and partner closely with R&D and commercial teams to enable successful drug development, registration and commercial continuity in China.
Key Responsibilities:
- Develop and implement optimal regulatory strategies for new product development and life cycle management that align with global, regional and China objectives.
- Prepare and deliver high-quality, on-time regulatory submissions and secure approvals for CTAs, NDAs/BLAs, variations, renewals, etc. according to China requirements.
- Serve as the primary liaison with China regulatory agencies; Lead health authority interactions in China including briefing books, face-to-face or virtual meetings, and drive timely, effective responses to health authority queries.
- Monitor and interpret changes in drug registration related regulations and guidelines in China; assess their impacts on existing products and future development programs.
- Identify regulatory risks and partner with cross-functional teams to develop and implement mitigation plans.
- Communicate regulatory strategy, status, timelines, risks and business implications clearly to cross functional stakeholders.
- Collaborate closely with R&D, QA/Compliance, Supply Chain and Commercial teams to support drug development, registration, launch and lifecycle activities.
- Provide regulatory input on new regulations and guidelines, and advise on their impact to drug development, product launch and business continuity.
- Ensure regulatory activities in compliance with applicable regulations, company policies and RA department SOPs.
Qualifications & Competencies
- Master’s degree or above in chemistry, pharmaceutics, biology or a related life-science discipline.
- More than 5 years of regulatory affairs experience in a multinational pharmaceutical company.
- Experience in pharmaceutical R&D and leading regulatory strategy development for new assets. Strong familiarity with China regulatory systems and requirements.
- Growth mindset with strong collaboration, communication and influencing skills in a matrix organization. Demonstrated leadership and learning agility.
- Excellent English communication skills (spoken and written); proficient computer skills and strong story telling/presentation abilities.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility