Công ty Luật TNHH Luật Việt

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

• This position is responsible for managing the product registration in Vietnam.

Responsibilities

• Develop, maintain and update the processes for product registration and license changes.

• Manage preparation, submission and follow of initial and renewal product registrations, variations.

• Prepare registration dossier, ensure that the drug registration dossiers are submitted to the authorities on time with accurate information.

• Closely follow up the status of application from the time of submission until getting approval.

• Keep tracking of registration status, submissions, approval and registration timeline.

• Coordinate and provide regulatory guidance to international regulatory staff of principals on registration requirements.

• Communicate clearly with the DAV staff/experts and Client on the query if any, based on the scientific of drug registration and regulations.

• Develop and maintain the working network with authorities and relevant organizations to carry out the product registration.

• Review and approve labels in relation to regulatory compliance.

• Review and approve promotional material, submit/get the authority’s approval for brochures.

• Brand Name Listing, GMP Listing

• Coordinate, provide, review the registered product information on requirement of other functions like marketing, tender, demand, supply and importation.

• Preparation of the Monthly Reports to Management

• Other tasks as assigned.

Job requirements

• Bachelor’s Degree in Pharmacy

• At least 5 years of managerial/specialist experience in Regulatory Affairs for the Pharmaceutical industry

• Good relationship with the authorities related to registration tasks (Ministry of Health, Drug Administration of Vietnam)

• Good knowledge and understanding of legal requirements related to product registration for pharmaceutical products

• Good verbal & written communication and negotiation

• Proficiency in Microsoft Offices

• Team Commitment (Must have the ability to work as part of a team to achieve common objectives

• Problem Solving (Strong analytical skills required. Must be able to manage many diverse projects simultaneously).

• Has good negotiation and interpersonal skills

• Fluency in English

• Planning and organizational skills

• Open and independent mind and attitude