CHC RA Executive
Pharmaceutical Company
Ho Chi Minh City
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
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Industry:
Pharmaceutical
Job Category:
Pharmaceuticals
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Location:
Ho Chi Minh City
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