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Senior Regulatory Affairs Executive

7 months ago

Hanoi, Vietnam Abbott Laboratories Full time

**_MAIN PURPOSE OF ROLE_**
- Plan, direct and monitor regulatory affairs to ensure 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 business, ensuring compliance to current Vietnam regulatory requirement. Proactively analyse, comment and communicate any changes in the regulatory environment
- Develop and facilitate relations with key Regulatory Authorities (DA,) and Institutes (Drug Quality Institutes...).

**_ MAIN RESPONSIBILITIES_**
- Primary contact with Drug Administration of Vietnam (DAV), Ministry of Health (MOH) and relevant Authorities:

- Liaise with government to ensure regulatory compliance.
- Establish and maintain positive relationship with government agencies and other regulatory authorities.
- Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement...) following the regulation. Supervise the registration of marketed product.
- Liaison with various distributors/consultants/DAV to facilitate the smooth registration activity.
- Understand and share current updates in regulations/new guidelines/circulars published by DAV.
- Evaluate and review registration dossiers for administration.
- Keep track of registration status, submissions and registration timeline.
- Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Abbott products.
- 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.
- Assure all audits so that organization and government standards on products/ processes are met.
- Consult on ongoing basis on related issues with management team.
- Ensure quality systems are in place and meet standard requirements for affiliate.

**_
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED _**

**_Work _**_Experience_**_ _**
- Minimum 3-5-year experience in pharma industry
- High level of autonomy at work

**_ Education_**
- Bachelor's Degree in pharmacy

**_ CORE Skills Required _**

Professional Skill
- Building partnerships
- Communication
- Information monitoring
- Negotiation
- Planning and organizing
- Problem solving & decision making

Behavioral / Leadership Skill
- Adaptability
- Initiative
- Innovation
- Integrity
- Teamwork
- Set vision and strategy
- Build our organization and inspire our people
- Know the business
- Drive for result
- Make the difficult decision
- Encourage open exchange of ideas and knowledge

Language Skill
- Fluent English (written and verbal)

Computer Skill
- MS Office
- Abbott Vietnam Employees must comply with the requirements relating to Abbott Quality system and Abbott Quality policies to perform their job responsibilities_._._