APAC Regulatory Strategy Director, International

3100 Roche Singapore Technical Operations, Pte. Ltd.; Singapore; On-site; SGD 220,000 - 340,000; Full time

Job summary

Roche is seeking a Senior Regulatory Affairs PTR Lead for the APAC region. The role oversees a regulatory CMC submission team, shaping end-to-end filing strategies and ensuring right-first-time submissions to Health Authorities.

You will collaborate with global PTR leaders, regional affiliates, and regulatory authorities to accelerate product registrations. Education includes a PhD/MC in science or related field, with 15+ years in pharma and strong international CMC experience.

Qualifications

• PhD/MC degree required.
• 15+ years of experience in the pharmaceutical industry.
• Significant experience in Regulatory Affairs/CMC for small molecule and biologic products, with international market exposure.

Responsibilities

• Lead the PTR International team and manage regulatory submissions across APAC.
• Develop and implement end-to-end local filing strategies aligned with global plans.
• Collaborate with global PTR Leaders, Technical Regulatory Teams and regional affiliates to drive efficient submissions.
• Liaise with regulatory authorities to facilitate prompt reviews and approvals.
• Manage budgets and resources to ensure timely regulatory milestones and market access.

Skills

PTR leadership

Regulatory strategy

Stakeholder management

Team leadership

Education

PhD/MC in science or related area

Job description

Roche is seeking a Senior Regulatory Affairs PTR Lead for the APAC region. The role oversees a regulatory CMC submission team, shaping end-to-end filing strategies and ensuring right-first-time submissions to Health Authorities.

You will collaborate with global PTR leaders, regional affiliates, and regulatory authorities to accelerate product registrations. Education includes a PhD/MC in science or related field, with 15+ years in pharma and strong international CMC experience.