Senior Legal Counsel

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Legal & Compliance Job Sub Function: Law Business Partners Job Category: Professional All Job Posting Locations: Beijing, China, Shanghai, China Job Description: Job Description: Senior Legal Counsel, Regulatory Law China, Innovative Medicine At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Legal Counsel, Regulatory Law China, Innovative Medicine. Purpose: The Johnson & Johnson Global Legal Organization is recruiting a regulatory lawyer to provide regulatory legal support and strategic legal guidance to its Innovative Medicine business in China, including policy work and external environment engagement, to help shape and successfully implement business strategies, service offerings and go-to-market models in China. You will be responsible for: Providing legal support and advice on the varied and complex legal and regulatory requirements affecting innovative medicines for the full product lifecycle, such as issues related to human genetic resources regulation, clinical development, post-market vigilance, product quality escalations, late lifecycle management of mature products, health care compliance, and in-licensing or acquisition of external assets and divestment or out-licensing of internal assets. Serving as the key legal contact for, and providing strategic advice and guidance to, various functional groups on regulatory legal matters across China, notably Regulatory Affairs, Quality, Medical Affairs, Good Clinical Practice Compliance, Medical Safety, Government Affairs & Policy. Serving on the local legal entities’ Marketing Authorisation Holder Board and Domestic Responsible Entity Board and supporting the overseas marketing authorisation holder legal and regulatory requirements. Maintaining up-to-date knowledge of pharmaceutical legislation in China and providing regulatory legal analysis and guidance to R&D and business colleagues on the interpretation of critical legislative developments, such as innovative regulatory pathways and pilot programs (e.g. Greater Bay Area, Bo’Ao), regulation of advanced therapies (e.g. cell and gene therapies), and digital and AI-related regulatory developments within scope of good practice quality standards and guidelines. Engaging in external regulatory and policy initiatives with industry associations and J&J policy teams. Providing training and guidance to business and legal partners on regulatory legal updates of interest. Undertaking other regulatory legal work aligned with company priorities in response to changing regulatory requirements. The role will report to the Legal Director - Regulatory Law APAC within the Regulatory Law group for Innovative Medicine. Qualifications / Requirements: Have a LL.B. or J.D., obtained with excellent results, and have a China National Bar certificate. A supplementary degree or LL.M. is considered an asset. Fluency in Mandarin and English (both written and spoken). Have at least 7 years’ post-qualification experience in legal work (ideally regulatory legal) in the pharmaceutical or other life sciences and healthcare industries, acquired in: a reputable local law firm or an international law firm; and/or a legal department of a multinational corporation in the healthcare industry. Experience with the US or European regulatory environment is an asset. Demonstrate excellent strategic and analytical skills and the ability to help business partners find creative and compliant solutions to novel issues. Ability to assess risk and to handle challenging situations or high levels of ambiguity effectively. Be an effective communicator with a consultative style capable of interacting with senior business leaders and participating on cross-functional teams. Have a positive attitude and the ability to work collaboratively within teams and with legal colleagues and business partners at all levels of seniority. Be able to work independently in a fast-paced environment, with global teams located in multiple time zones. Location: Beijing, China (strong candidates based in Shanghai will also be considered). If based in Beijing, minimal travel. If based in Shanghai, up to 15% of the time. Required Skills: Preferred Skills: Analytical Reasoning, Business Agility, Commercial Laws, Compliance Management, Corporate Governance, Dispute Resolution, Lawyering, Legal Services, Litigation, Negotiation, Organizing, Process Improvements, Representing, Strategic Thinking, Tactical Thinking, Technical Credibility