Assoc Director, Regulatory Affairs China - Immunology

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.