Senior Manager, APAC Regulatory Strategy

Johnson & Johnson; Singapore; On-site; SGD 150,000 - 200,000; Full time

Job summary

A leading healthcare company is seeking an Associate Director for APAC Regulatory Affairs based in Singapore. This role involves leading the regulatory strategy and execution for pharmaceutical products across the Asia-Pacific region. The ideal candidate will have 8-10 years of experience in the pharmaceutical industry and a strong background in regulatory affairs. They will work collaboratively with global and regional teams and manage Health Authority interactions to ensure compliance and optimize product registration processes. A Bachelor's degree in a health-related discipline is required, and excellent communication skills are essential.

Qualifications

• Minimum 8 – 10 years of relevant pharmaceutical industry experience, preferably in a strategic role.
• Ability to communicate clearly with senior management and influence cross-functional decisions.

Responsibilities

• Define and drive end-to-end regulatory strategy for AP markets.
• Lead AP product registrations including input into CMC and Registration dossiers.
• Manage Health Authority interactions in AP.
• Oversee multiple regulatory projects concurrently.
• Communicate regulatory status and risks to senior management.
• Collaborate with R&D, Clinical, QA/Compliance, Regulatory Operations, and Commercial teams.

Skills

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

Education

Bachelor’s degree or equivalent in Pharmacy, Life Sciences, or a health-related discipline

Job description

A leading healthcare company is seeking an Associate Director for APAC Regulatory Affairs based in Singapore. This role involves leading the regulatory strategy and execution for pharmaceutical products across the Asia-Pacific region. The ideal candidate will have 8-10 years of experience in the pharmaceutical industry and a strong background in regulatory affairs. They will work collaboratively with global and regional teams and manage Health Authority interactions to ensure compliance and optimize product registration processes. A Bachelor's degree in a health-related discipline is required, and excellent communication skills are essential.