Assoc Director, Regulatory Affairs China - Immunology

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

在我们的信条指引下，强生公司对全球范围内与我们共事的员工负有责任。我们提供一个包容的工作环境，在这里每个人都被视为独立的个体。在强生，我们尊重员工的多样性和尊严，并认可他们的价值。

工作职能：Regulatory Affairs Group

作业子功能：Regulatory Affairs

职位类别：Professional

所有职位发布位置：Beijing, China

职位描述：
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:
产品授权, 法规遵从, 法律支持, 分析推理, 风险规范, 风险评估, 公共政策, 基于事实的决策制定, 技术可信度, 监管环境, 监管开发, 监管事务管理, 商务写作, 师徒制, 行业分析, 战略性思维, 组织