Regulatory Affairs Assistant

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 RoleFosters close working relationships with the RA Executive, and when needed, the Management Team and other operational business department/section heads in communication, development, and follow-up of regulatory matters for Zuellig Pharma Sdn. Bhd. Maintenance of regulatory requirements in accordance to the service scope contracted with Clients in accordance to the requirements of the industry the Ministry of Health. What You’ll Do : Responsible for the follow-up on the agreed plan and timelines for Registration Projects to meet client and internal stakeholder objectives.

Monitor and update changes of regulatory affairs and government policies related to healthcare and support the Regulatory Affairs Unit, on matters pertaining to regulatory affairs matters as necessary. Keep abreast of general knowledge of pharmaceutical and/or healthcare products and the market to provide relevant insights and advice to the internal team. Work closely with internal and external stake holders to ensure all responsibilities and agreed services for clients are met. Understand and adhere to company's SOP, including but not limited to Regulatory AffairsSOP.

Understand the different business models and key processes related to Zuellig Pharma's Operations and structure that will affect services and responsibilities. Act as a Deputy for the Safety Contact or Back-Up during the absence of the Primary Safety Contact which includes: Reporting all relevant safety information relating to the medicinal product to Ministry of Health (MoH), in accordance with the local requirements stipulated in this guideline. Aware of and to ensure compliance with any local post-marketing requirements, obligations or commitments relating to the safety of the medicinal product, e. g. safety restrictions imposed on use of medicinal products.

Respond promptly to any request from MoH for the provision of information necessary for the benefit-risk evaluation of a medicinal product, e. g. list of purchasers. Provide prompt inputs, when required by MoH, on significant safety concerns so that timely and appropriate regulatory action(s) can be taken, e. g. safety communications to healthcare professionals or patients, press releasesCompleting operational requirements of a pharmacist, including verifying not limited to application of import permits, order entries, maintaining records of controlled substances and etc.

Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practicePromote and adhere to Zuellig Pharma’s core values when carrying out day-to-day responsibilities and interactionsPerforms other duties as assigned when required. What will make you successful: Must-Have: 1 years of working experience with bachelor's degree in pharmacy, science or related field. Advantage to Have: Communication SkillsPlanning & Organization SkillsProblem Solving and Decision MakingWhat 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.