Regional Regulatory Affairs Pro — Accelerate Market Access

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

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.