Regulatory Affairs and Compliance Executive

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: 

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. Do translation of these if required.
• Day to day communication with individual client upon submission requirements, pending documents, submission update, feedback from the HA and approvals.
• 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.
• 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.
• Daily follow up with the HA and/or HA online portal on submission approval and requirements and report to Regulatory Affairs Manager.
• Checking with the HA on classification of the product and response accordingly and prepare weekly report and/or monthly report about submission, requirement, approval and regulation change and submit to regulatory manager.
• Assiting in performing and oversight in Compliance monitoring activities - Live Monitoring and Joint Field Visit
• Assisting in Ethics & Compliane (E&C) Integrity Week celebaration
• Assisting in Ethics & Compliance Communications projects when required

What will make you successful: Competent person with sound knowledge of all the regulatory guidelines and process

Must-Have:

Sound experience of RA operation, procedure and requirements

At least 1.5 years of working experience in regulatory and/or compliance environment

Has a sense of business acumen

Differentiate of urgency and priority

Advantage to Have:

Good command of English in both verbal and written

Self-driven and goal oriented

Problem solving skill and positive attitude

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.

Zuellig Pharma  is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to any characteristic protected by local, state, or federal laws, rules, or regulations.

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