JAPAC Regulatory Affairs Manager – Strategy & Submissions

one stop engineering pte. ltd.; Singapore; On-site; SGD 150,000 - 190,000; Full time

Job summary

one stop engineering pte. ltd. is seeking a Manager, Regulatory Affairs to lead JAPAC regulatory strategies for late-stage and marketed products.

You will partner with R&D, commercial teams and affiliates to drive submissions, health authority interactions and strategic regulatory planning. You will coordinate with cross-functional teams to ensure timely approvals, compliant data packages, and proactive risk management across diverse JAPAC markets.

Qualifications

• Bachelor’s degree in pharmacy, pharmacology, biology or related field; advanced degree preferred.
• Minimum 5 years in Regulatory Affairs with ≥3 years in JAPAC regulatory affairs, end-to-end with ND registrations, health authority interactions and CTAs.
• Comprehensive knowledge of JAPAC regulatory requirements and processes; experience with oncology compounds is a plus.
• Strong interpersonal, communication and cross-functional collaboration skills; ability to influence stakeholders.

Responsibilities

• Lead and execute regional RA initiatives for JAPAC in partnership with global, area, and affiliate teams and ensure timely project delivery.
• Serve as primary RA liaison to affiliate teams and maintain clear communication channels.
• Coordinate with local health authorities and prepare briefing materials aligned with regulatory strategy; ensure timely communications to stakeholders.
• Assess data for submissions and ensure compliance with JAPAC/regional requirements; identify gaps and develop mitigation strategies.
• Present regulatory data to RA affiliates and ensure timely responses for SA/CTA submissions and other regulatory actions.
• Collaborate with Commercial, Medical Affairs, Market Access, Clinical Development, and CMC teams to enable product registrations and mitigate regulatory risks.
• Develop Area Regulatory Strategy and implement regulatory plans for JAPAC in collaboration with Global Regulatory Lead and RA teams.
• Represent regional and affiliate regulatory requirements in Global Regulatory Product Teams and ensure alignment across stakeholders.

Skills

Regulatory affairs

Cross-functional collaboration

Communication skills

Interpersonal skills

JAPAC regulatory knowledge

Education

Bachelor’s degree in pharmacy, pharmacology, biology or related

Advanced degree preferred

Job description

one stop engineering pte. ltd. is seeking a Manager, Regulatory Affairs to lead JAPAC regulatory strategies for late-stage and marketed products.

You will partner with R&D, commercial teams and affiliates to drive submissions, health authority interactions and strategic regulatory planning. You will coordinate with cross-functional teams to ensure timely approvals, compliant data packages, and proactive risk management across diverse JAPAC markets.