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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:
Associate Director, Immunology TA, China Regulatory Affairs
Key Responsibilities
1. Regulatory Strategy Development and Execution
- Develop and execute end-to-end regulatory strategies for assigned immunology assets and indications in China, spanning early development, late-stage development, NDA/BLA submission, review, approval, and post-approval lifecycle management.
- Provide strategic input to global regulatory strategy plan, asset development plan, and project-related discussions to ensure China-specific considerations are incorporated early and effectively.
- Identify opportunities to optimize regulatory pathways, accelerate regulatory approvals, enhance registration success, and maximize patient access.
- Assess regulatory risks and uncertainties; collaborate with cross-functional teams to develop and implement effective mitigation plans.
- Provide regulatory leadership to address complex regulatory challenges and drive the resolution of critical regulatory issues.
2. Regulatory Expertise and Strategic Assessment
- Maintain deep understanding of the China regulatory environment, evolving regulations, health authority expectations, industry trends, competitor intelligence, and the immunology therapeutic area.
- Monitor and assess evolving regulatory requirements, policies, and agency expectations that may impact product development and registration.
- Translate changes in the regulatory environment into actionable recommendations and regulatory strategy adjustments to support development, approval, and lifecycle management of assigned assets.
3. Regulatory Submission and Approval
- Develop China regulatory submission strategy and timeline for assigned assets and get alignment with cross-functional stakeholders across China, regional and global teams.
- Partner with RE, RMC and NGS teams to deliver regulatory submissions, including CTA, NDA/BLA, supplements, variations, and renewals, and achieve regulatory milestones.
- Ensure regulatory activities are effectively planned, tracked, and executed to support timely approvals.
- Review key submission documents, health authority response and labeling content to ensure scientific rigor, quality, consistency and regulatory compliance.
4. Health Authority Interaction
- Develop and execute health authority interaction strategies, including consultation meetings and regulatory communications.
- Lead interactions with regulatory agencies to facilitate alignment on development plans, submission strategies, and key regulatory issues.
- Develop and coordinate high-quality, data-driven responses to health authority questions and information requests.
- Lead the preparation of briefing books, presentation materials, and supporting documentation for regulatory agency meetings.
5. Stakeholder Management and Business Partnership
- Represent China Regulatory Affairs on Global Regulatory Teams, China Project Teams, and other cross-functional forums for assigned assets.
- Act as a strategic partner to cross-functional and business teams, ensuring regulatory considerations are integrated into key decisions.
- Communicate regulatory strategies, submission/approval timeline, key risks, and significant regulatory developments to relevant stakeholders in a timely manner.
6. Coaching & Knowledge Sharing
- Provide coaching and guidance to junior RA colleagues and contribute to their professional development.
- Share regulatory expertise and best practices to promote regulatory excellence across the team.
Job Requirements
- Bachelor’s degree or above in Pharmacy, Chemistry, Biology, or a related life sciences discipline; advanced degree preferred.
- Minimum 10 years of regulatory affairs experience in multinational and/or leading pharmaceutical companies.
- Strong experience in drug development and registration across multiple products and development stages.
- In-depth knowledge of China regulatory requirements, guidelines, regulatory processes, and health authority expectations.
- Proven ability to work effectively in cross-functional and matrix team environments.
- Strong strategic thinking, problem-solving, communication, influencing, and stakeholder management skills.
- Therapeutic area experience in Immunology is preferred.
- Excellent written and verbal communication skills in both English and Chinese.
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