CHC RA Executive
N.A.TOPJOBS' CLIENT
Pharmaceutical Company
Ho Chi Minh City
Posted
91 months ago
Duties & Responsibilities:
Prepare registration dossiers for CHC products as local regulations and Company policies. Submit registration dossiers to MoH of Vietnam as time manner. Monitors the progress of the assessment with MoH of Vietnam and co-ordinate with ROPU/Corporate in order to achieve products licenses as the plan.
Prepare registration dossiers and co-ordinate with partners in Cambodia to submit and achieve products licenses in Cambodia
Perform maintenance activities depending on local or regional requirements such as variation on CCDS or CMC, renewal of MAA in VN & CBD.
Involve in CPD 3, SLCI system and other relevant system
Regulatory Compliance to ensure local implementation and compliance with Corporate Policies, Processes, Procedures and Guidelines relevant to DRA activities
Work closely with Marketing Team to submit and get the health authorities approvals for promotional materials of products in Vietnam as regulation.
Work closely with Marketing Team to submit and get the health authorities approvals for symposia in hold in Hanoi
Handle technical product complaints
Requirements:
Pharmacist/doctor with a background in RA
Experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality and compliance
Highly motivated and results-oriented
Proven expertise in all aspects of Regulatory Affairs; Submission Prep, All Phases of RA Regulations and Requirements/Procedures
Project Management, Negotiations
Proficiency in local RA compliance
Excellent written and verbal communication, technical writing, and editing skills
Detail-oriented
Fields marked with a * are required.
Company Size:
200-500
Industry:
Pharmaceutical
Job Category:
Pharmaceuticals
Job Type:
Full Time
Location:
Ho Chi Minh City
Desired skills:
English
Job Level:
Executive
Preferred language to receive applications:
English
Company address:
53/7 Nhieu Tu Str., Ward 7, Phu Nhuan Dist., HCMC, Vietnam
Contact name:
Ms. Nguyen Thi Lan Phuong
Phone number:
08 6292 6671 Ext: 103
Email address:
phuong.lan.nguyen@natopjobs.com.vn
myha@natopjobs.com.vn
recruitment@natopjobs.com.vn
ltnhan@natopjobs.com.vn