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About the Role

The Regulatory Affairs Director is a key member of the Global Regulatory Affairs organization, serving as the regulatory regional office for the Immunology portfolio. This role provides strategic leadership for the local regulatory affairs department in Asia Pacific, implementing regional and local regulatory strategies for assigned products and projects. The position also contributes regional input into the global regulatory strategy, identifies regional requirements for successful filings, and oversees early portfolio assets before pivotal Phase 3 studies. Additionally, it ensures adequate preparation for health authority meetings and provides technical expertise on new diseases and regulatory guidance.

Responsibilities

Provides direction for regulatory activities related to products/projects in the Immunology therapeutic area.
Works with head office-based liaisons and local operating companies to define and implement regional and local strategy for assigned products.
Manages development and implementation of multi-national/regional regulatory strategies to optimize development, registration, and lifecycle management.
Expedites regulatory approval of new products, new indications, and line extensions by providing early regional regulatory inputs.
Provides technical expertise and guidance to local affiliates on strategies to accelerate submissions/approvals.
Provides input into label and TPP, leads strategic discussion on label pre and post registration.
Provides regional implementation and regulatory-based advice on new and updated Company Core Data Sheets.
Maintains expert knowledge in regional regulatory requirements and ensures staff expertise.
Manages regulatory interactions with local operating companies and regional functions.
Serves as point of contact with local operating companies.
Ensures collaborative relationships with key stakeholders including staff, R&D, business partners, and senior management.
Interacts with local operating companies on individual products/processes.
Facilitates discussions with local operating companies on regional or global regulatory issues.
Provides guidance to local operating companies to determine timing and strategy for regional HA meetings.
Participates in preparations for interactions with HAs and assists operating companies.
Acts as the primary contact with multifunctional regional teams such as Commercial Strategic Marketing, Market access, supply chain, legal and patent.
Leads regulatory activities on regional cross-functional teams.
Provides input to submission tactical planning and timelines, including lifecycle submissions.
Ensures maintenance of content plans for submissions in the region.
Reviews and provides input to critical submission documents.
Delivers on business-critical regulatory submissions in accordance with priorities and timelines.
May participate in “Rapid Response Teams” for HA questions.
Ensures tracking of submission and approval milestones.
Ensures tracking of regional post-approval commitments.
Has people management/oversight responsibilities for regional regulatory staff and local regulatory staff.
Provides coaching and guidance to department and local affiliates’ regulatory staff.
Participates in developing talent development strategy.
Responsible for management of regional in-licensed registration submissions.
Participates in the development of department processes and procedures.
Updates HQ regulatory staff regarding changes in regional regulatory requirements.
Provides support to Regional Head to develop metrics for the region.

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.
Ability to work in a matrix environment.
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.
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.

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

Location

Beijing, China
Chiyoda, Tokyo, Japan
Singapore, Singapore

Work Type

Full-time

Experience Level

Director
10+ years experience
5+ years regulatory experience

Education Level

Bachelor's degree or equivalent in pharmacy or life-science or health-related discipline

About the Company

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.
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.

Equal Opportunity

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.