Senior Regulatory Affairs Professional APAC

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-109229, Japan R-109230, Singapore R-108587

 

 

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 Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job 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 OVERVIEW:

 

The Senior RA Professional is a member of the Global Regulatory Affairs organization.  The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.  

 

The position, under supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.

CORE RESPONSIBILITY:

• As a member of the AP regional regulatory team, you will provide strategic regional regulatory input for assigned products across Asia-Pacific, supporting timely registrations, lifecycle management and ongoing compliance. You will partner with local operating companies, Global Regulatory Teams and regional functions to translate global strategy into region-specific regulatory plans and deliverables.

ROLE DESCRIPTION:

• 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.

REQUIRED QUALIFICATIONS:

• 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.

PREFERRED QUALIFICATIONS:

• 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 & COMPETENCIES:

• Regional Regulatory Strategy
• HA Engagement & Submissions
• Labeling & Lifecycle Management
• Stakeholder & Cross-Functional Collaboration
• Decision Making & Risk Management
• Regulatory Intelligence
• Project & Priority Management
• Communication & Influence

ADDITIONAL INFORMATION:

• Operates independently with limited managerial oversight, setting longer-term priorities in consultation with supervisor.
• 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.

 

 

 

Required Skills:

 

 

Preferred Skills:

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