Regulatory Affairs & Quality Assurance Specialist

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

We advance science so that we all have more time with the people we love.

The Opportunity

We are seeking a detail-oriented Regulatory Affairs & Quality Assurance Specialist I to support our organization in ensuring regulatory compliance and maintaining quality standards for 3PL warehouse operations. This role involves overseeing product printing processes, maintaining quality documentation, and ensuring adherence to safety and regulatory requirements.

• Support compliance with quality assurance standards for 3PL warehouse operations, including local customization of imported goods
• Oversee product printing for Roche Diagnostics Pakistan in line with DRAP (Drug Regulatory Authority of Pakistan) requirements, providing line clearance, in-process checks, and approvals
• Maintain and update SOPs for quality management at the 3PL warehouse, ensuring adherence to established processes
• Serve as a checkpoint for final and in-process product release authorization
• Prepare and submit registration dossiers for medical devices to DRAP, ensuring timely follow-ups and necessary updates for approved products
• Liaise with global regulatory teams and DRAP to resolve regulatory issues and ensure compliance with local regulations
• Assist with GDPMDS (Good Distribution Practice for Medical Devices) audits and maintain the Pakistan Medical Device Register (PMDR) in SAP
• Complete all required safety and compliance training and immediately report any safety-related product information to the Local Safety Responsible (LSR)
• Adhere to Symphony, compliance, and PRI/PSI procedures
  
  
  

Who You Are

• Bachelor’s degree in Pharmacy, Life Sciences, or a related field
• Previous experience in regulatory affairs or quality assurance preferred
• Familiarity with DRAP regulations and medical device registration is a plus
• Strong organizational skills, attention to detail, and proficiency in SAP and Microsoft Office
• Effective communication skills in both English and Urdu
  
  

What do we offer

Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes.

We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.