Regulatory Affairs Manager

ABOUT ZUELLIG PHARMA
Zuellig Pharma (ZP) is one of the largest healthcare services groups in Asia and our purpose is to make healthcare more accessible.
For past 100 years, we have been the trusted partner for healthcare companies looking to realize opportunities in Asian markets. With our deep-reaching infrastructure and sole focus on healthcare, we offer our clients unparalleled access to all healthcare channels across 13 countries in the region. Our focus is always about combining our market insight with a thorough understanding of your needs to deliver the best solution that connects you to patients. We believe delivering your products is only the first step to capturing the Asian markets. That is why we have continued to invest in developing innovative solutions that expand across Logistics, Clinical Reach, Sales & Marketing, Patient Centered Services, and Community Pharmacies.
ZP THERAPEUTICS
Beside Logistics service, Zuellig Pharma group also provide commercial solution to our clients under business unit: ZP Therapeutics. ZP Therapeutics is the partner of choice for companies looking for a sales and marketing partner in Asia. With offices in 13 markets across Asia and over 2,500 associates, our commercial excellence, in-market capabilities and strong ethical principles have driven the group's success as a trusted partner for the healthcare industry.
Purpose of Position
- To manage product registrations in line with MOH regulation
- Manage one Regulatory Affairs Executive at least
Responsibilities
- Develop, maintain and update the processes for product registration, trademark and license changes
- Manage preparation, submission and follow of initial and renewal product registrations, variations
- Review and approve labels in relation to the regulatory compliance
- Coordinate, provide, review the registered product information of principals on requirement of other functions like marketing, tender, importation ,..
- Coordinate and provide regulatory guidance in pharma fields to the team, other functions and principals. Proactively analyze, comment and communicate any changes in the regulatory environment.
- Develop and maintain the working network with MOH, associations and relevant organizations to carry out drug registration, cosmetic, medical device
- Support the Regulatory Affairs Team to ensure high quality of registration dossier and following with the local authority. Effectively manage and accelerate registration approval.
- Other tasks as assigned