Regulatory Affairs Manager

Hanoi - Vietnam

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description

To ensure timely product registrations that are in compliance with related regulatory requirements.

Managing well all projects on registration and maintaining license of products for sporting business.

PRIMARY ACTIVITIES

1. Primary activities 1

Prepare plan and set up process for filing new medicine applications and maintenance of registration of existing company products with regulatory authorities in timeline required.

Notify regulatory authorities of changes to medicines.

Maintain the process for update label based on requirement of Global for products responsible the monitoring of packaging and labeling.

Assist in the monitoring of PV system if any.

Assist for Product quality control together with SCM Team if any.

2. Primary activities 2

Obtain regulatory approval within optimum timelines and subsequently ensure new products are made accessible in the fastest time possible.

Ensure immediate regulatory authority notification in relation to medicine changes.

Help to maintain high quality and accurate packaging and labelling of company products.

Develop and implement time and cost saving initiatives for this role.

Develop and implement services to assist in delivering better value to customers.

Specific measures as per personal performance grid.

Good collaboration with other function team for supporting business.

Desired Experience/Education:

University graduate major in medicine/pharmacy

Prior experience in the pharmaceutical industry at least 3 years .

Familiar with policies and procedures of Ministry of Health.

Good working knowledge of applicable Laws and Regulations.

Relevant knowledge of the health industry.

Relevant knowledge of products and options.

Competent in English language.

Required Skills:

Accountability Accountability Adaptability Audits Compliance Business Management Business Strategies Delivering Value Detail-Oriented Drug Regulatory Affairs Employee Training Programs English Language Global Communications Manufacturing Compliance Mentorship Motivation Management Pharmaceutical Management Pharmaceutical Regulatory Affairs Pharmacovigilance Process Improvements Process Planning Project Management Quality Control Management Regulatory Affairs Management Regulatory Compliance Regulatory Management 5 more

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Required Experience:

Manager

Job DescriptionTo ensure timely product registrations that are in compliance with related regulatory requirements.Managing well all projects on registration and maintaining license of products for sporting business.PRIMARY ACTIVITIES1. Primary activities 1 Prepare plan and set up process for filing ...