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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 atJob Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations:
Bangkok, Bangkok, Thailand, Beijing, China, Chiyoda, Tokyo, Japan, Hong Kong, Hong Kong, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Seoul, Korea, Republic of, Singapore, Singapore, Taipei City, Taiwan
Job Description
Johnson & Johnson is seeking an Assoc Dir APAC Regulatory Leader to join the APAC Regulatory Affairs team.
Position Summary
The Senior Manager APAC Regulatory Leader 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 neuroscience products.
The position 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.
Markets in scope of responsibility are:
China, Japan, South Korea, Taiwan, Hong Kong, Australia, New Zealand, South East Asia and India. As the position is also a core member of the AP regional cross functional team, there is also.
Core Responsibility
As a core member of the AP regional cross functional team, you will be leading the regulatory strategy and execution for pharmaceutical assets across the Asia-Pacific region, ensuring timely registrations, lifecycle management, and ongoing compliance.
What You'll Do
Define and drive end-to-end regulatory strategy for AP markets, aligning with global, regional and local objectives.
Lead AP product registrations, including input into the preparation, compilation, and management of CMC and Registration dossiers to ensure submissions meet local requirements.
Manage Health Authority interactions in AP (briefing documents, questions, responses, and post-submission activities).Oversee multiple regulatory projects concurrently; set milestones, timelines, and resource needs; mentor junior staff.
Communicate regulatory status, risks, and implications to senior management.
Collaborate with R&D, Clinical, QA/Compliance, Regulatory Operations, and Commercial teams.
Contribute to labeling updates and Core Data Sheet regional inputs; track post-approval commitments.
Monitor regulatory intelligence and advise on regional impact to global development roadmaps.
Ensure compliance with regulatory and quality standards; maintain thorough documentation and audit readiness.
Required Qualifications
Bachelor's degree or equivalent in Pharmacy, Life Sciences, or a health-related discipline.
Minimum 8 – 10 years of relevant pharmaceutical industry experience, preferably in a strategic role in a core regional function.
Ability to communicate clearly with senior management and influence cross-functional decisions.Preferred Qualifications
Experience in a relevant field of pharmaceutical Research & Development, such as but not limited to clinical science or development.
Experience leading regulatory strategic development for assets at regional/global levels, and experience registering pharmaceutical products in AP; strong familiarity with AP regulatory systems and requirements.
Proven track record driving HA interactions/engagement and supporting local submissions (CMC and/or Registration dossiers) is a plus.Possess a growth mindset and strong business acumen to drive optimal regulatory strategy and contribution.
Demonstrated program/portfolio management, organizational skills, and ability to manage multiple priorities.
Strong cross-cultural collaboration in a matrix environment.
Skills & Competencies
Regulatory Strategy & Planning
HA Engagement & Submissions Management
Cross-Functional Collaboration
Communication to Senior Leadership
Project Management & Mentoring
Dossier Preparation (CMC/Registration)
Lifecycle Management & Labeling
Regulatory Intelligence & Risk Assessment
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