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About the Role

The Senior RA Professional is a member of the Global Regulatory Affairs organization, residing in the AP Region. This role is responsible for defining and implementing the regional strategy for assigned products by working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams, and other global functions. The position leads and provides region or country strategic input into the global regulatory strategy and identifies regional requirements to optimize registration and lifecycle management of marketed products, considering current and proposed changes in regulatory requirements and standards. This position provides regional affiliates with timely responses to Health Authority enquiries and offers general regulatory support to all affiliates in the region for the pharmaceutical sector business.

Responsibilities

Provide strategic regional regulatory input for assigned products across Asia-Pacific, supporting timely registrations, lifecycle management and ongoing compliance.
Partner with local operating companies, Global Regulatory Teams and regional functions to translate global strategy into region-specific regulatory plans and deliverables.
Advise the Global Regulatory Team (GRT) and Compound Development Team (CDT) on regional regulatory requirements, guidelines and issues impacting product strategy; participate as a standing GRT member where applicable.
Provide regional input to expedite new indications and line extensions, and guide local affiliates on strategies to accelerate submissions and approvals.
Serve as point of contact for local operating companies and support preparation for Health Authority (HA) interactions, including timing and strategy for HA meetings.
Provide input to submission planning and timelines, including lifecycle submissions (labeling changes, renewals and safety reports), and review critical submission documents.
Participate in Rapid Response Teams to ensure timely, appropriate responses to HA questions.
Contribute to regional implementation of Core Data Sheets; under supervision, review labeling revisions and support labeling negotiations with HAs.
Track submission and approval milestones and regional post-approval commitments, ensuring follow-up and ongoing compliance.
Provide AP evaluation in licensing activities, monitor regional regulatory changes and update global teams on their impact.
Contribute to department processes and support VP, Regulatory Affairs AP initiatives as requested.

Requirements

Bachelor’s degree or equivalent in Pharmacy, Life Sciences, or a health-related discipline.
2 – 8 years of overall relevant pharmaceutical industry experience, preferably including regulatory experience.
Excellent verbal and written English communication skills, including the ability to communicate with senior management.
Hands-on experience registering pharmaceutical products in AP countries and familiarity with AP regulatory systems and requirements.
Experience preparing Health Authority submission documents (Chemistry & Manufacturing and/or Registration dossiers) and in HA interactions.
Understanding of drug development and/or marketed products, including awareness of AP pricing, reimbursement and supply chain impacts on registration.
Demonstrated ability to manage multiple projects, with strong organizational skills.
Proficiency in Mandarin or other Asian languages.
Cultural sensitivity and ability to thrive in a multicultural, matrix environment as a proactive, adaptable team player.

Skills

Regional Regulatory Strategy
HA Engagement & Submissions
Labeling & Lifecycle Management
Stakeholder & Cross-Functional Collaboration
Decision Making & Risk Management
Regulatory Intelligence
Project & Priority Management
Communication & Influence
Analytical Reasoning
Business Writing
Coaching
Collaboration
Communication
Legal Support
Problem Solving
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Regulatory Reporting
Risk Assessments
Strategic Thinking

Location

Chiyoda, Tokyo, Japan

Work Type

Minimal regional business travel (1–2 times per year); occasional international travel may be required.
Flexible hours required to accommodate early morning/evening meetings across time zones.

Experience Level

2 – 8 years of overall relevant pharmaceutical industry experience, preferably including regulatory experience.

Education Level

Bachelor’s degree or equivalent in Pharmacy, Life Sciences, or a 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 arePrevention, treatment, and cure, 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.
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