MÔ TẢ CÔNG VIỆC:
1, Regulatory Compliance:
- Ensuring that company's products comply with the local regulation;
- Stay up-to-date with local, national, and international regulations and standards pertaining to pharmaceuticals, cosmetics. functional food, insect repellent and medical devices;
- Checking monthly intellectual property gazette and providing advice/warning to senior management of the products;
- Support in training to internal teams on regulatory matters, ensuring a company-wide understanding of compliance requirements.
2, Product Registration:
- Preparing submissions of licence variations and renewals to strict deadlines pertaining to pharmaceuticals, cosmetics. functional food, insect repellent and medical devices;
- Developing and writing clear arguments and explanations for product licences;
- Monitoring and setting timelines liaising with, and making presentations to regulatory authorities.
3, Cross-functional Collaboration
- Collecting, collating and evaluating scientific data that has been researched by colleagues;
- Advising scientists and manufacturers on regulatory requirements;
- Review and check for product labeling and packaging materials from Marketing dept. to ensure compliance with regulatory requirements;
- Collaborate with R&D, Manufacturing, Marketing, and other departments to align regulatory requirements with product development and commercialization goals;
- Collaborate with relevant departments to execute the company's strategic initiatives (ISO 14001, Cosmetic GMP, CE Marking Certificate, etc.)
4, Collection and management of post-market surveillance and pharmacovigilance information
- Receiving, recording, and monitoring the database of all reports related to drug safety (ADRs, medication errors, suspected adverse events (AE) related to medicines, etc.) from various sources (healthcare professionals, medical examination and treatment facilities, etc.);
- Preparing and submitting periodic safety update reports (PSURS) in accordance with regulations.
5, Follow other duties required from Manager.
YÊU CẦU CÔNG VIỆC:
Job Requirement
- Bachelor's Degree OR Master Degree - Science & Technology Major (Pharmacy, Chemical Engineering/ Biotechnology or equivalent)
- Fresh graduate or at least 1 year experience in RA
- Good command of English (speaking, reading, writing)
- Proficient in MS Office
THÔNG :
Other Information:
Probation: 2 months of probation with full salary
Working time: 44 hours/week
Training:
A2E skill training
Pre-mortems
Prioritization
Problem-solving
Owner's mindset
Idea generation
Coaching
Influencing
Courageous conversations
Effective communication
Presenting with impact
Closed-loop conversations
Creating business value
Effective meetings
Effective emailing
Organizational health
Colleagues: Friendly & Supportive
Annual Leave:
- 15 working days: from full 1 year to less than 3 years;
- 16 working days: from full 3 years to less than 7 years;
- 22 working days: from full 7 years or more to less than 37 years.
Benefits:
Japanese Health Insurance for Staffs over 2 years contribution
Company trips, Team building activities
Holiday events
Other Allowances:
Meal allowance
Company bus from HCMC to Factory
Parking fee