Senior Regulatory Affairs ExecutiveAbbott Nutrition International
Hình thức: Toàn thời gian
Ngày đăng: 12/03/2024
Hạn nộp: 12/04/2024
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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..
Giới thiệu công ty
Abbott Nutrition International
Tầng 8, 2 Ngô Đức Kế, Bến Nghé, Quận 1, Hồ Chí Minh
nutrition.abbott Abbott.com abbottnutrition.com.vn/ glomed.vn abbott.com
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Vị trí Senior Regulatory Affairs Executive do công ty Abbott Nutrition International tuyển dụng tại Hà Nội, Joboko tự động tổng hợp mức lương Thỏa thuận, tìm thêm việc làm về Senior Regulatory Affairs Executive hoặc công ty Abbott Nutrition International ở các link phía trên
Giới thiệu công ty
Abbott Nutrition International
Tầng 8, 2 Ngô Đức Kế, Bến Nghé, Quận 1, Hồ Chí Minh
nutrition.abbott Abbott.com abbottnutrition.com.vn/ glomed.vn abbott.com