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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, ensuring successful implementation of regional and local regulatory strategies for assigned products. The position also contributes regional insights to the global regulatory strategy and identifies regional requirements for successful regulatory filings, including the placement of clinical trials. Additionally, it offers leadership and portfolio review for early-stage assets before pivotal Phase 3 studies and guides the preparation for health authority meetings.

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 strategies for assigned products.
Manages the development and implementation of multi-national/regional regulatory strategies to optimize development, registration, and lifecycle management.
Expedites regulatory approval of new products, indications, and line extensions by providing early regional regulatory input.
Provides technical expertise and guidance to local affiliates on strategies to accelerate submissions/approvals.
Provides input into label and TPP, and leads strategic discussions 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 the point of contact with local operating companies.
Ensures collaborative relationships with key stakeholders including staff, R&D, business partners, and senior management.
Facilitates discussions with local operating companies on regional or global regulatory issues.
Provides guidance to local operating companies on timing and strategy for regional HA meetings.
Participates in preparations for interactions with HAs and assists operating companies with these interactions.
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 staff in LOCs.
Provides coaching and guidance to department and local affiliates’ regulatory staff.
Participates in developing talent development strategies.
Is a member of the Asia-Pacific leadership team.
Responsible for the 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.
Makes proposals and negotiates on prioritization and trade-offs on a project level.
Provides input to department strategic objectives, goals, and performance measures.
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.

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.
At least 5 years of regulatory experience.
Hands-on experience in pharmaceutical product registration in AP countries.
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.
Must be able to 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.

Skills

Regulatory Strategy
Applied Technical Knowledge
Business Acumen
Decision Making and Prioritization
External Focus
Leading and Influencing
Persuasive Communication
Analytical Reasoning
Business Writing
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
Good understanding of the pharmaceutical industry
Detailed knowledge of local laws, regulations and guidance in the region related to full drug life cycle.
Understanding of how laws, regulations and guidance apply to specific projects.
Ability to interpret them and understand them in the context of the scientific and commercial environment.
Good understanding of and experience in drug development and/or marketed products.
Ability to anticipate and influence regulatory developments in the region and assess business impact
Understanding of the scientific and medical principles applicable to the therapeutic area and specific products.
Awareness of pricing and reimbursement issues in AP
Understanding of how supply chain decisions impact registrations in AP
Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.
Ability to work with and influence HA actions and outcomes.
Project-related knowledge of commercial/medical business needs.
Broad understanding of scientific data (CMC, clinical and non-clinical)
Comprehensive understanding of the needs of regional business partners.
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.
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
Understanding of resources, time, expertise, etc. required to complete projects
Mentoring skills
Line management skills

Location

Chiyoda, Tokyo, Japan
Asia Pacific region

Work Type

Full-time

Experience Level

Director
Minimum of 10 years of relevant pharmaceutical industry experience
At least 5 years of regulatory experience

Education Level

Minimum of 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.