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A dedicated regional regulatory director for immunology across China, Japan and Singapore signals that J&J is treating Asia-Pacific immunology drug approvals as a standalone strategic priority rather than an extension of US or EU filings.
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.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
China R-108931, Japan R-108932, Singapore R-107981
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Beijing, China, Chiyoda, Tokyo, Japan, Singapore, SingaporeJob Description:
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
POSITION SUMMARY:
The Regulatory Affairs Director is a member of the Global Regulatory Affairs organization and is the regulatory regional office for the Immunology portfolio reporting to the therapeutic immunology head. This product responsibility includes leadership responsibility for Nipocalimab and early portfolio.
The position is required to provide strategic leadership input for local regulatory affairs department in Asia Pacific and successfully implement the regional and local regulatory strategy for products / projects in the assigned therapeutic area. The position is also responsible for providing region or country input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications, including the opportunity for placement of clinical trials within the region. This position is also required to provide leadership and portfolio review for all the early portfolio assets before going into pivotal Phase 3 study.
This position also should provide leadership together with the local RA team to ensure adequate preparation for health authority meetings, and attend and provide presentations to health authorities, where necessary.
As immunology is a therapeutic area with many new diseases, the technical expertise of the position to guide the development and understanding of new diseases for the local regulatory affairs team and extended team is also important.
The position also needs to provide high-level oversight for product variations, including labeling changes, supplements, and amendments; timely responses to Health Authority inquiries; as well as regulatory support to all affiliates in the region for the pharmaceutical sector business.
The position resides in Asia Pac region.
PRINCIPAL RESPONSIBILITIES for Regulatory Affairs Director, Asia Pacific
Regulatory Strategy and Expertise
Health Authority, Operating Companies, and Business Partner Interactions
Regulatory Submissions
People Management
Additional Responsibilities:
Required Leadership Competencies (J&J Regulatory Affairs Competency Model):
Required Technical Competencies & Knowledge:
Regulatory Strategy
Regulatory Input into Other Functions
• Comprehensive understanding of the needs of regional business partners.
Submissions
• Detailed knowledge of laws, regulations, and guidance as they apply to submissions in the region.
• Knowledge of what is needed for dossier components and submissions, how to obtain regional components and how long it will take to gather it. Understanding of documentation requirements.
• Ability to analyze reports to determine whether they meet regulatory requirements, and are consistent with the regulatory strategy.
Labeling
• Knowledge of local labeling requirements.
• Ability to critically review labeling development/labeling revisions and assess impact on relevant countries
• Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling.
• Experience in labeling negotiations with health authorities
Resource Planning and Management
• Understanding of resources, time, expertise, etc. required to complete projects
• Mentoring skills
• Line management skills
DECISION-MAKING AND PROBLEM-SOLVING:
• Must make proposals and negotiate on prioritization and trade-offs on a project level.
• Provides input to department strategic objectives, goals and performance measures.
• Independence in decision-making regarding regional strategies with supervisor approval.
• Defines operational priorities and tactics. Resolves conflicts in priorities in consultation with supervisor, liaison team leader, business partners and internal customers.
• Presents issues and solutions to senior management in the region and Health Authorities.
• Determines risk-management strategies for projects.
• Makes informed decisions by soliciting input from others where needed.
• Makes complex decisions in situations with multiple, ambiguous objectives and constraints.
Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these.
Independence/Autonomy:
Operates independently in a complex environment. Independent in daily activities, with very limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor and regulatory liaison team leader. Position makes determination of routine work issues.
REPORTING RELATIONSHIPS:
Reports to Senior Director, Regional Regulatory Immunology Head
Will have direct line supervisory responsibility.
WORKING RELATIONSHIPS/INTERFACES:
Internal:
(1) Within Global Regulatory Affairs:
Including GRL, and GRT members, TASLT and CDT, C-ROSS MS: as needed by project activities to establish project objectives and strategies and ensure knowledge sharing.
(2) Local Regulatory staff, as needed by project activities to develop and evaluate drug project strategies and objectives and ensure knowledge sharing to enhance product development and registration activities.
(3) Regional Integrated Value Team (IVT) and Cross-Functional Team (CFT) which includes Commercial, Market Access, Supply Chain, Medical Affairs, GCO, Communication, and other Regional Teams as needed for projects
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
• Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline.
• Minimum of 10 years of relevant pharmaceutical industry experience, including at least 5 years of regulatory experience
• Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements. Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and/or Registration dossiers)
• Demonstrated leadership and contribution to drug development strategies
• Demonstrated ability to handle multiple projects.
• Demonstrated organizational skills
• Ability to communicate to senior level management.
• Working knowledge of regulations
• Experience in HAs interactions.
• Experience specifically in the region is a mandatory requirement
• Excellent verbal and written communication skills – proficiency in written and oral English
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required
• Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Proficient use of technology including AI and MS Office.
WORKING CONDITIONS/TRAVEL REQUIREMENTS:
• Position is located in the Asia Pac region. Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones
• Regional business travel (20-30%) is required.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Tactical Planning, Technical Credibility
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