JOB DESCRIPTION:

ROLES & RESPONSIBILITIES

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's business, ensuring compliance to current Vietnam regulatory requirement.

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. 
• To be assigned as SME (Subject Master Expert) of Pharmacovigilance, contact point with PV team in relation to products of Abbott Healthcare Vietnam Co., Ltd

People Management:

• Support employees in implementing of their growth plans. Develop and maintain succession plan and address future staffing issues in a proactive manner.
• Manage team’s development throughout the path to achieve goals.
• Ensure team activities to comply with Company Business Code of Conduct and all local applicable laws within scope of function responsibility.
• Special projects as needed by Management team.

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

Work Experience: >7 years’ experience in Regulatory, prefer pharmaceutical MNC. Experience in leading a team of RA professionals
 

CORE Skills Required:

• 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 & English
Computer Skill: MS office

MINIMUM EDUCATION REQUIRED

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

     

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 > Thuan An : Binh Duong Plant 1

     

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)