Executive, Regulatory Affairs

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

Purpose of The Role:

The Regulatory Affairs Executive works within the Regulatory Team to prepare and submit registration of pharmaceutical products and medical devices. With the guidance from the Head of Regulatory Affairs, Regulatory Affairs Executive advises and guides clients to prepare and ensure product registrations are maintained, and service levels are met

What You’ll Do: (Maximum 10 points)

• Be responsible for and follow the agreed plan and timelines for Registration Projects to meet client and internal stakeholder objectives
• Ensure compliance, monitor, and update changes related to regulations set by local Regulatory Agencies and support the Head of Regulatory Affairs on other regulatory affairs matter when necessary

• Ensure continuous knowledge update on the registration process for Pharmaceuticals, Biotech, Health Supplements, Generics, Medical Device, Veterinary and Cosmetics in Malaysia

• Work closely with internal and external stakeholders (i.e. Pharmacovigilance, Marketing, Quality Assurance, Finance, Regulatory Authorities) to ensure all the responsibilities and agreed services for the clients are met.

• Understand and adhere to company’s regulatory affairs SOP

• Full understanding on the business models and key processes related to Zuellig Pharma’s operations and structure that will affect services and responsibilities 

• Support the Regulatory Affairs team for any regulatory affairs adhoc requests, not limiting to Product Review, Regulations, Guidelines.

• Maintains accurate KPIs/metrics and provides to Head of Regulatory/appropriate function in a timely manner.

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  Coordinate and provide support for Regulatory Affairs audit/inspection activities, quality investigations, CAPA creation and implementation for Zuellig Pharma.

• Promote and adhere to Zuellig Pharma’s core values when carrying out day-to-day responsibilities and interactions

What Will Make You Successful:

• Demonstrate solid understanding of applicable regulations, guidelines and submission requirements and applies them accurately in day to day work. 
• Attention to detail - product high quality, accurate dossier and documentation with minimal errors ensuring compliance to regulatory requirements. 
• Ownership and accountability - takes responsibilities for assigned products/clients and proactively resolves issues. 
• Planning & execution - effectively prioritizing multiple registration projects
• Problem solving mindset - identify risk early and propose practical solutions
• Stakeholder management - build strong working relationships with internal and external stakeholders. 
• Learning Agility - keep abreast on the requirements to balance decision amking and compliance to ensure business objectives are met. 
• Continuous improvement - enhance efficiency and contribute to a culture of operational excellence. 
• Integrity and professionalism - upholds highest ethical standards, maintains confidentiality and ensure regulatory compliance in all activities. 

Must-Have: (Maximum 4 points)

• Bachelor's degree in Pharmacy (preferred), Life Sciences, Biomedical Science, Chemistry, Biotechnology or related field. 
• Understanding of local Health Authority requirements (e.g NPRA, MDA and etc). 
• Knowledge of product registration lifecycle (new registration, variations, renewals). 
• Familiar with ACTD/eCTD dossier structure. 
• Good understanding of GxP principles (GMP, GDP, GCP as relevant). 
• Ability to interpret guidelines and regulations. 
• Ability to manage multiple projects simultaneously
• Good communication skills especially with Health Authorities and Internal Stakeholders. 
• Problem-solving mindset
• Integrity and accountability. 

Advantage to Have: (Maximum 8 points)

• Experience in handling ASEAN submissions
• Experience with multiple product categories:
  • Pharmaceuticals
  • Medical Devices
  • Cosmetics
  • Health Supplements
• Experience interacting directly with Health Authorities
• Specialized Knowledge in the following:
  • Pharmacovigilance
  • Promotional Review
  • Regulatory Intelligence
  • Change Control
  • Artwork and labeling review
  • Lifecycle management
• Digital Skills
  • Quest 3+
  • Veeva Vault RIM
  • Microsoft Applications

What We Offer:

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.

• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.

• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.

• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.

• Our Total Rewards program is designed to support your overall well-being in every aspect.