Associate Regulatory Affairs Manager, Pharmaceuticals Division

abbott· 1156 ABT Healthcare Vietnam
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📍 Vietnam - HanoiFull time

About this role

     

JOB DESCRIPTION:

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.


WORKING AT ABBOTT

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

  • Career development with an international company where you can grow the career you dream of.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

MAIN PURPOSE OF ROLE:

  • Plan, direct, and monitor regulatory affairs so that the organization has the permits, license, certificate, authorization, and other approvals it needs to conduct its current and future business activities.
  • Maintain local SOPs and Regulatory policies and provide support to Abbott Healthcare business, ensuring compliance to current Vietnam regulatory requirement.

  • Reporting to Regulatory Affairs Manager
  • Working Location: Handi Resco Tower, Kim Ma, Hanoi

MAIN RESPONSIBILITIES:


Primary contact with DAV, MOH and relevant Authorities:

  • Liaise with government to ensure regulatory compliances.
  • Establish and maintain positive relationship with government agencies and other regulatory authorities.

Regulatory affairs’ key focuses:

  • Liaise with functional managers to understand their short to medium-term business goals (for example introducing a new product, service, operating process, entering a new market) and develop plans, cost estimates, schedules for acquiring the necessary permits/ approvals.
  • Owns ultimate accountability for the function and provide advice, recommendations on company regulatory compliance.
  • Ensure the organization regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations/ laws and standards.
  • Assure all audits so that organization and government standards on products/ processes are met.
  • Consult on ongoing basis on related issues with management team.
  • Supervise the registration of marketed product.
  • Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution, and sale of Abbott products.

Support to QA, Manufacturing and Marketing activities:

  • Provide consultation where needed to Operations, QA and Commercial team on suitability/ acceptability of new product submissions supporting document as per Vietnam regulatory standards.
  • Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
  • Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.
  • Local SOPs and policies:
  • Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with Abbott global SOPs & policies and DAV and VN MOH requirements. 

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

Work Experience

>7 years’ experience in Regulatory in pharmaceutical company. Experience in leading a team of RA professionals

Education

Field of Study-Qualification

Bachelor

  • Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam.

CORE Skills Required

Professional Skill

Technical skills required for role

  • Ability to handle high levels of pressure and critical decision-making
  • Good leadership, interpersonal, teambuilding, and problem-solving skills
  • Skilled communicator with well-developed verbal, written and presentation ability
  • Strategic thinking                                         
  • Planning, Organizing and Coordination                                                
  • Ability to learn
  • Good Relationship building/ Networking
  • Work organization & Priority management

Behavioral / Leadership Skill

Apply Abbott Capabilities Framework

Language Skill

  • Vietnamese/ Tiếng Việt
  • English/Tiếng Anh

Computer Skill

(any specific Computer Skill required)

  • MS Office

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Vietnam > Hanoi : Handi Resco Tower

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

     

     

Frequently Asked Questions

Is the salary disclosed for the Associate Regulatory Affairs Manager, Pharmaceuticals Division position at abbott?
The salary for this Associate Regulatory Affairs Manager, Pharmaceuticals Division role at abbott is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Associate Regulatory Affairs Manager, Pharmaceuticals Division position at abbott located?
This Associate Regulatory Affairs Manager, Pharmaceuticals Division role at abbott is based in Vietnam - Hanoi. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Associate Regulatory Affairs Manager, Pharmaceuticals Division role at abbott full-time or part-time?
This is listed as a Full time position. It is posted as a Associate Regulatory Affairs Manager, Pharmaceuticals Division role in the 1156 ABT Healthcare Vietnam department at abbott.
Which team or department does the Associate Regulatory Affairs Manager, Pharmaceuticals Division at abbott belong to?
This Associate Regulatory Affairs Manager, Pharmaceuticals Division position is part of the 1156 ABT Healthcare Vietnam department at abbott. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Associate Regulatory Affairs Manager, Pharmaceuticals Division position at abbott?
Click the "Apply Now" button on this page. You will be redirected to abbott's official application portal hosted on workday where you can submit your application directly.
When was the Associate Regulatory Affairs Manager, Pharmaceuticals Division job at abbott posted?
This Associate Regulatory Affairs Manager, Pharmaceuticals Division position at abbott was posted on Oct 8, 2026. Apply as soon as possible — early applications are often reviewed first.
Associate Regulatory Affairs Manager, Pharmaceuticals Division
abbott
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