Regulation Affair Manager

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Recruitment Information

1. Work location: Ho Chi Minh
2. Industry: Biotechnology , Medical / Healthcare , Pharmaceutical
3. Job level: Manager
4. Job type: Permanent
5. Salary: 1,400 - 2,000 USD

 

Job description

• Responsible for defining regulatory strategies and submissions in supporting of new and existing marketing authorizations for products;
• Responsible for acting in compliance with Vietnam policies and practices to reduce principal’s exposure to regulatory, quality and liability risks;
• Accountable for relationship and communication with Regulatory Authorities;
• Guide relationships with regulatory authorities to facilitate interactions on behalf of Principal/manufacturer for critical issues;
• Set-up and develop and regulatory plans for complex projects including new projects and maintenance of existing marketing authorizations;
• Suggest changes and finalize dossiers prepared at Head Office;
• Lead the preparation of dossiers for visa in Vietnam;
• Build, maintain Relationships with Government’s Quality Control Labs in Vietnam territory and following up testing results in Government’s QC Labs. Suggest the best suitable way to settle quality problems.

Job Requirement

• Bachelor degree in pharmacy/ medicine preferred.
• Equivalents experience as Regulatory Affairs Manager in OTC Pharmaceutical sector.
• Good command of English.

 

Required Job Skills

acting policies communication otc

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