Manager, Regulatory Affairs, APAC

Manager, Regulatory Affairs, APAC

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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.

The Manager, Regulatory Affairs will join the Regulatory Affairs APAC team 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 resides in the AP Region and is accountable for leading and providing region or country strategic input into the global regulatory strategy 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.

Responsibilities

• Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region‑specific regulatory issues with impact on the product strategy or deliverables. Keeps up‑to‑date on understanding of regional / regulatory environment.
• Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
• Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs.
• Provides guidance to local affiliates on development of strategies to accelerate submissions / approvals.
• Provides input in post‑registration activities, including labeling changes, including regional implementation and regulatory‑based advice on new and updated Core Data Sheets.
• Maintains expert knowledge in regional regulatory requirements and ensures that staff is expert in country and product‑specific regulatory requirements.
• Provides AP evaluation in licensing activities.

Health Authority, Operating Companies, and Business Partner Interactions

Regulatory Submissions

Additional Responsibilities

Required Technical Competencies And Knowledge

Regulatory Strategy

HA And Operating Company Interactions

Submissions

Labeling

Decision Making and Problem–Solving

Independence / Autonomy

Knowledge, Education, Experience, Communication Skill Requirements

Required Skills

Preferred Skills

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