United International Pharma

Mô tả Công việc

The Regulatory Affairs Assistant Manager is responsible for planning, preparing, and monitoring dossiers for approval related to the registration, notification, and certification of local and imported products. This role involves managing BE projects, evaluating dossiers for GMP assessment, providing regulatory updates, and other projects. The Assistant Manager also ensures compliance with government regulatory requirements in Vietnam and participates in packaging design checks and barcode management.

• Plan registration activities based on new product line-up.
• Request, review, and prepare registration/ notification/ variation documents for drugs, cosmetics, and food supplements according to the plan.
• Monitor and follow up on data/information gathering and dossier compilation for product registration and submission.
• Consult involved internal and external entities on regulatory requirements to perform the assigned tasks and provide advice to related departments as needed.
• Handle BE projects for assigned drugs including contact and consult with BE Centers (Ha Noi and HCM) to obtain prices and timelines, purchase comparator drugs for BE Testing in the Plant. Assist in data/information gathering and dossier compilation for BE Testing in BE Centers.
• Monitor the status of and prepare licenses/certificates and check/prepare documents for registration/certification, including Satisfaction of Drug Trading Condition certificate (SDTC), Pharmacist licenses, GMP, CoPP, FSC certificates.
• Other related licenses/certificates registration.
• Participate in checking packaging design for registration and production.
• Handle advertising tasks including review and/ or prepare documents for advertising and conferences, ensure compliance with regulations.
• Check and prepare additional documents related to feedback on registration/notification/certification documents from health authorities.
• Drug pricing registration.
• Medical device registration.
• Check reports to MOH/DAV/SOH for importation/exportation of raw materials, packaging materials, and finished medicinal products, manufacturing and market distribution of local medicines.
• Monitor, provide, and manage barcodes for Vietnam.
• Monitor and update product information on the Regulatory Affairs website.
• Assistant for RA&SC Director.
• Handle projects and tasks assigned by line manager.

Yêu Cầu Công Việc

Professional Background

• Bachelor’s degree in Pharmacy or related field, MBA preferred. 
• At least 5 years of relevant regulatory affairs experience.
• Project management experience.
• Fluent in English.  

Competency Requirements

• Good knowledge on regulations related to pharmaceuticals, food supplements, cosmetics and medical device registration.
• Proficiency in Microsoft Office software, especially Microsoft Word, Excel, and PowerPoint.
• Strong communication, presentation, and time management skills.
• Collaboration, growth and positive attitude mindset.