APAC Regulatory Strategy Lead

Biopharma Asia

Singapore

On-site

SGD 110,000 - 170,000

Full time

2 days ago
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Job summary

Johnson & Johnson in Singapore seeks a Senior Regulatory Affairs Professional to shape regional regulatory strategy for Asia‑Pacific products. You will work with local affiliates, Global Regulatory Teams and cross‑functional partners to optimize registrations and lifecycle management.

You will provide expert input on regional requirements, expedite new indications and lead submissions planning, while ensuring timely responses to Health Authority inquiries and ongoing regional compliance.

Qualifications

  • Bachelor’s degree in Pharmacy, Life Sciences, or a health-related discipline.
  • 2–8 years of relevant pharmaceutical industry experience, preferably including regulatory experience.
  • Excellent verbal and written English communication skills, including the ability to communicate with senior management.

Responsibilities

  • Provide strategic regional regulatory input for assigned products across Asia‑Pacific, supporting timely registrations, lifecycle management and ongoing compliance.
  • Translate global strategy into region‑specific regulatory plans and deliverables with local operating companies and regional teams.
  • Advise Global Regulatory Team on regional requirements and issues impacting product strategy; participate as a standing GRT member where applicable.
  • Provide input to expedites new indications and line extensions, guiding local affiliates on submissions and HA interactions.
  • Track submission and approval milestones and regional post‑approval commitments with follow‑ups.

Skills

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

Education

Bachelor’s degree in Pharmacy/Life Sciences/health discipline

Job description

Johnson & Johnson in Singapore seeks a Senior Regulatory Affairs Professional to shape regional regulatory strategy for Asia‑Pacific products. You will work with local affiliates, Global Regulatory Teams and cross‑functional partners to optimize registrations and lifecycle management.

You will provide expert input on regional requirements, expedite new indications and lead submissions planning, while ensuring timely responses to Health Authority inquiries and ongoing regional compliance.

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