Job Description
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: To ensure that products license are valid, especially in regulated industries like pharmaceuticals and medical devices, cosmetic,… comply with all relevant laws and regulations. This includes obtaining and maintaining product approvals, ensuring compliance throughout the product lifecycle, and acting as a liaison between the company and regulatory agencies.
What You’ll Do:
- Serve as full time liaison personnel with the FDA drug section, food section, and Medical device and cosmetics section for all the new registration application, renewal registration, variation, notification, one time permit application, DIAC/ DIAC attachments applications, sticker application and advertisement application.
- Update about regulation change, update on change of procedure and requirement of HA related to the regulatory submission and industry practices. Make translation (if any).
- Daily follow up with the HA and/or HA online portal on submission approval and requirements and report to Regulatory Manager.
- Prepare weekly report and/or monthly report about submission, requirement, approval and regulation change and submit to regulatory manager.
- Checking with the HA on classification of the product and response accordingly.
- Checking and preparing the registration/variation/notification dossier shared by the clients, communication with individual client upon submission requirements and submit timely manner and feedback the response of the HA.
What Will Make You Successful:
- Arranging the FDA samples shipments, including but not limited to, communication with clients, following up with couriers such as DHL, TNT, FedEx, EMS, etc.. on shipment and clearing status, checking samples upon receiving, managing redressing activities (if any) and preparing requirements to get readiness of samples submission as required.
- Follow company's Code of Conduct and fully aware of it and compliant with company policies.
Must-Have:
- Education : Bachelor's degree in pharmacy
- Language : Must possess a good command of English
- Good communication in English
- Above average oral and written communication skills
- Demonstrate ability to lead and develop Human Resources staff.
- Demonstrate ability to serve as a successful participant on the executive management team.
Advantage to Have:
- Negotiation skill
- Self-driven and goal oriented
- Problem solving skill and positive attitude
- Has a sense of business acumen
- Differentiate of urgency and priorityGood command of English in both verbal and written
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.
#LI-SN1