Senior Regulatory Affairs Executive

Abbott Laboratories. GmbH

Địa điểm làm việc: Hà Nội

Hết hạn: 12/04/2024

Chi tiết công việc
Giới thiệu công ty

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pháp lý y tế

JOB DESCRIPTION

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.
Closely follow up the status of application from the time of submission until getting approval.
Support Marketing team in applying advertisement licenses & detail aid material printing permits.
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..

Thông tin chung

Ngày hết hạn: 12/04/2024
Thu nhập: Thỏa thuận

Giới thiệu công ty

Tại Abbott, chúng tôi luôn giúp các nhân viên thành công, dẫn đầu và vươn lên, cùng với những thách thức và tưởng thưởng, công việc của chúng tôi tạo ra sự khác biệt thật sự trong cuộc sống con người trên toàn thế giới.
Fortune: Xếp trong danh sách "Những công ty nổi bật nhất" của Hoa Kỳ từ 1984 đến nay.
Barron's: Đứng thứ 15 trong danh sách các công ty được đánh giá cao nhất và đứng thứ 2 trong danh sách các công ty hàng đầu về chăm sóc sức khỏe năm 2009
BusinessWeek: Xếp trong danh sách "50...

Quy mô công ty

Từ 1000 - 5000 nhân viên

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