Head, Quality & Regulatory Affairs, Singapore

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. Its 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.

Thats 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 organisations 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 Bachelors 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 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.