Associate Regulatory Specialist

4 days ago

Petaling Jaya, Selangor, Malaysia George Clinical Pty Full time

Join to apply for the Regulatory Specialist role at George Clinical.

At George Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncology—areas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need.

Why Join Us?

At our core, George Clinical is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you'll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here's what makes us stand out:

  1. Purpose-Driven Work: You'll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
  2. Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
  3. Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

About the Role

The Regulatory Specialist undertakes specific regulatory tasks required for the implementation of clinical trials by George Clinical. The Regulatory Specialist contributes updates in local clinical trial related regulatory requirements to the George Clinical central library of related information.

Your Responsibilities

  • Develop regulatory and other project related documentation as required and ensure these are kept up to date.
  • Maintain a current knowledge of applicable clinical trial related regulatory information for designated countries.
  • Ensure updates to clinical trial related regulatory processes for designated countries are shared with George Clinical head office in a timely manner.
  • Support development and maintenance of clinical trial related regulatory SOPs, WIs and ADs for designated countries.
  • Support internal training on clinical trial related regulatory processes for designated countries.
  • Liaise with Study team, sponsor and Investigators as applicable to prepare clinical trial related documents for submission to regulatory authorities.
  • Act as local regulatory representative for any submissions to or requests from the regulatory authority of designated countries.
  • Collate, track and review regulatory documents and packages according to project and country specific requirements and timelines.
  • Provide project specific updates and metrics relating to local regulatory submission status as required by project team.
  • Provide regulatory support for project related activities such as country level feasibilities, observational studies, background research activities for proposals.
  • Ensure project files are kept up to date.
  • Liaise with Regulatory services vendors, if applicable.

About You

  • Tertiary qualification in a related science or health care discipline.
  • Associate Regulatory Level Position: We are looking for candidates with 1-2 years of experience in regulatory affairs and a background in clinical trials.
  • Regulatory Specialist Position: We are looking for candidates with 3-5 years of experience in regulatory affairs, with a strong understanding of regulations and guidelines. Proficiency in Cantonese is preferred.
  • Previous experience in clinical trial related regulatory document preparation and submissions.
  • Excellent working knowledge of ICH/GCP, ethical and regulatory requirements.

What We Offer

We understand that great work happens when people feel valued and supported. That's why we provide:

  1. Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
  2. Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
  3. Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
  4. Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
  5. Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.

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