Regional Regulatory Affairs Specialist

F. Hoffmann-La Roche AG; Dubai; On-site; AED 300,000 - 480,000; Full time

Job summary

Roche in Dubai seeks a Regulatory professional to support regional regulatory affairs for commercial operations, including premarket and postmarket registrations. You will liaison with health authorities and internal teams to ensure timely product access across markets.

Responsibilities include dossier preparation, agency engagement, tender documentation, and change management, with emphasis on cross‑functional collaboration and ongoing compliance.

Qualifications

• Minimum 3 years of regulatory experience
• Experience in medtech is a plus
• Strong communication and cross‑functional collaboration skills

Responsibilities

• Prepare, compile, and submit regulatory dossiers for new product launches, line extensions, and renewals across the region
• Interact with health authorities and regulatory bodies to secure clearances and maintain approvals
• Provide regulatory documentation (certificates, declarations) to support tenders and business contracts
• Evaluate product, labeling, and manufacturing changes for regulatory impact and submit change notifications
• Educate cross‑functional teams, advise senior leadership on regulatory trends, and review promotional materials for compliance
• Collaborate with Quality and Safety leads on adverse event reporting, recalls, and audits
• Refine regulatory processes and regional governance to align with evolving regulations across the region

Skills

Regulatory

Project management

Cross-functional collaboration

Analytical skills

Communication

Job 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

The Opportunity

The role will support the Regional Regulatory providing support on any regulatory affairs matters required for commercial operations.

Main Responsibilities

• End-to-End Premarket & Postmarket Registrations: Prepare, compile, and submit high-quality regulatory dossier packages for new product launches, line extensions, and renewals to ensure seamless market access and continuous product availability across the region.
• Agency Engagement & Advocacy: Directly interact and negotiate with health authorities and regulatory bodies to secure rapid, optimal product clearances, approvals, and regulatory maintenance.
• Commercial & Tender Enablement: Partner closely with Marketing, Product Management, Sales, and Logistics to provide required regulatory documentation (certificates, declarations) to support commercial tenders and business contracts.
• Lifecycle & Change Management: Evaluate product, labeling, and manufacturing changes for regulatory impact, submitting change notifications and updating local control/tracking systems in compliance with regional standards.
• Cross-Functional Advisory & Capacity Building: Act as the internal Subject Matter Expert (SME) to educate cross‑functional teams, advise senior leadership on critical regulatory trends, and review/approve promotional materials for compliance.
• Quality, Safety & Postmarket Compliance: Collaborate with Product Quality and Safety leads to fulfill adverse event reporting, recall management requirements, and support internal and external audit activities.
• Process Optimization & Regional Governance: Continuously assess and refine internal regulatory processes, tracking tools, and regional network communications to align local practices with evolving regional regulations.

Who you are

• Required experience and competencies - A minimum of 3 years of experience in regulatory - within medtech industry is a plus
• Experience in project management and the ability to manage multiple priorities in a fast-paced environment.
• Familiarity with regulatory policy frameworks and a keen interest in staying updated with global regulatory trends is a plus
• Strong analytical skills and the ability to interpret complex regulatory information.
• Ability to collaborate seamlessly across multi-disciplinary teams and drive shared business objectives
• Excellent communication skills, both written and verbal, with proficiency in creating clear and compelling presentations.

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.