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 Specialist ensures timely regulatory approval and ongoing compliance of pharmaceutical and healthcare products across their lifecycle, supporting successful market access and commercialization. The role works cross-functionally and with Regulatory Health Authorities to identify risks, interpret evolving regulations, and execute regulatory strategies that enable speed to market while maintaining full regulatory compliance.
This position is also part of our Talent Pipeline, intended to identify and engage strong potential candidates for future openings within the organization, offering the opportunity to be considered for meaningful and impactful roles as they become available.
What You'll Do:
- Evaluation and preparation of dossiers and technical documents for submission of new pharmaceutical and healthcare products.
- Ensure regulatory compliance of pharmaceutical and healthcare products throughout the product's lifecycle.
- Identify risks and gaps that may impact implementation of local regulatory and commercialization plans.
- Communicate and coordinate with various stakeholders (partners, cross-functional team, regional team, etc.) on regulatory status and updates.
- Represent the company with various Regulatory Health Authorities (FDA, PDEA, BAI, etc.).
- Prepare and review artworks and labels for packaging; review materials and ensure compliance through Veeva.
- Execute key regulatory actions to support business requirements.
- Ensure adherence to current and new regulations and cascade relevant updates from governing bodies.
- Ensure databases, reports, and trackers are updated and provided on time.
- Provide support to the Regulatory Affairs Director in terms of regulatory strategy and regulatory intelligence to ensure speed to market and compliance with regulatory guidelines; create SOPs and process updates to support the regulatory function; actively represent the company with trade associations and ensure key company advocacies are pushed across.
What will make you successful:
Must-Have:
- B.S. in Pharmacy graduate and a Licensed Pharmacist
- At least 12 years of experience in Regulatory Affairs
- FDA experience in product registration
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.
