Head, Quality & Regulatory Affairs, Singapore at F. Hoffmann-La Roche Ltd - Italy

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

07 Jul, 26

Salary

0.0

Posted On

09 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, Regulatory Affairs, Risk Management, Compliance, Strategic Leadership, Stakeholder Management, Product Registration, Audit Preparation, Data Privacy, Software Regulations, AI Regulations, Complaint Management, Agile Leadership, Biomedical Science, IVD Industry Knowledge

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Head of Quality & Regulatory Affairs, Singapore A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. As the Head of Quality & Regulatory Affairs, you are a senior leader accountable for overseeing all aspects of the Singapore affiliate business, ensuring our products and services meet the highest standards of safety and compliance throughout their lifecycle. You work as a strategic partner to business teams to ensure in depth transfer of requirements and information between internal product and regulatory teams with local stakeholders. Ensuring the translation of vital modular Quality Management System (mQMS) requirements into efficient local operations. You push the boundaries to implement smart, risk-based processes that ensure the Singapore affiliate remains a leader in the IVD industry while navigating an evolving regulatory landscape. Your Opportunity Affiliate Quality Leadership: You drive business results by ensuring the successful implementation of the mQMS. You monitor internal global metrics and KPIs, coordinate local management reviews, and lead the organisation’s preparation for required certifications and audits, e.g. SS GDPMDS certification. Regulatory Excellence: You take overall responsibility for regulatory submissions and product registrations across diverse portfolios, including Core Lab, Molecular Lab, Point of Care, Pathology Lab, and Digital Solutions. You ensure all local regulations are observed and implemented seamlessly across the company. Strategic Liaison: You serve as the primary external contact for the Health Sciences Authority (HSA) and industry bodies. You advocate for the IVD industry and coordinate closely with internal product regulatory teams to keep the affiliate informed of emerging global issues. Compliance & Risk Mitigation: You oversee the complaint management system and drive the review of promotional materials to ensure full compliance with local laws. You communicate significant quality or regulatory risks to Executive Management in a timely manner. You also serve as the Enterprise Risk Manager for the Singapore affiliate. Operational Oversight: You ensure all products maintain valid licensing and lead your team to develop and independently implement solutions that ensure daily work is completed without jeopardizing compliance. Innovation & Digital Readiness: At the intersection of evolving traditional diagnostics and software/AI regulations, you keep up with the trend and enable the organisation to face the latest regulatory requirements, ensuring data privacy requirements (PDPA) are integrated into our diagnostic data strategies. Who You Are Qualified Professional: You hold a Bachelor’s degree in Biomedical Science or an equivalent field; a medical laboratory background is preferred. Subject Matter Expert: You have at least 8 years of relevant work experience, with a recognized expertise in both Regulatory and Quality Affairs within the healthcare sector. Strategic Advocate: You have a proven track record of influencing external stakeholders and industry bodies. You possess the executive presence required to represent Roche in high-stakes quality and regulatory discussions. Digital Navigator: You demonstrate digital fluency, with experience navigating software/AI regulations and data privacy requirements (PDPA), which is considered a significant advantage in our evolving portfolio. Agile Leader: You are a role model for agile leadership behaviors, able to troubleshoot complex technical issues as they arise and lead a high-performing team in a fast-paced, regulated environment. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Head of Quality & Regulatory Affairs oversees all quality and regulatory aspects for the Singapore affiliate, ensuring compliance with local laws and global standards. They act as a strategic liaison with the Health Sciences Authority and manage risk mitigation, product licensing, and regulatory submissions.