Associate Regulatory Affairs Manager
7 months ago
**MAIN PURPOSE OF ROLE**
- Product registration including new, renewal, variations, special import license, promotional materials
- Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management
- Other tasks assigned by the line manager.
**MAIN RESPONSIBILITIES**
- 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.
- 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 (Drug Administration of Vietnam) 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.
**MINIMUM BACKGROUND/ EXPERIENCE REQUIRED**
**Work Experience**: >3 years experience in Regulatory, prefer pharmaceutical MNC
**CORE Skills Required**:
- Professional Skill_
- Time management
- Persuasiveness
- Good in working arrangement, teamwork
- Honest, careful, patient, highly responsible
- Language Skill:_ _Vietnamese/ Tiếng Việt & English/Tiếng Anh
- Computer Skill:_ MS office
**MINIMUM EDUCATION REQUIRED**
- Pharmacist/or Bachelor’s degree/or Medical Doctor
-
Regulatory Affairs Manager
6 months ago
Hanoi, Vietnam PERSOLKELLY Vietnam Full timeLocation: Hanoi - Salary: Negotiable - Industry: Pharmaceuticals **JOB DESCRIPTION**: - Report to: Board of Directors - Manage 3 staffs **Core Responsibilities**: - Complete submissions to MOH regulatory entities. - Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws. - Other duties as...
-
Regulatory & Public Affair Assistant Manager
7 months ago
Hanoi, Vietnam Manulife Full timeWe are a leading financial services provider committed to making decisions easier and lives better for our customers and colleagues around the world. From our environmental initiatives to our community investments, we lead with values throughout our business. To help us stand out, we help you step up, because when colleagues are healthy, respected and...
-
Regulatory Affairs Department Manager
6 months ago
Hanoi, Vietnam Talentnet Full time$2,000 - $2,500 **RESPONSIBILITIES**: - Set KPI/KGI and build action plan to achieve KPI/KGI - Support the subordinates to set KPI/ KGI and action plan to achieve KPI/KGI - Conduct performance appraisal for subordinates and make a consensus in the Department every year. - Manage product registration activities including drafting, reviewing, compiling, and...
-
Hanoi City
6 months ago
Hanoi, Vietnam L'Oreal Full time**Job descriptions**: - Provide technical and regulatory support throughout the product lifecycle, from initial research to final marketing - Supervise compilation of regulatory reports in line with quality standards and deadlines - Represent the company within technical groups run by professional associations - Monitor scientific and technical-regulatory...
-
Regulatory Affairs
6 months ago
Hanoi, Vietnam Reckitt Full timeHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...
-
Regulatory Affairs Executive
7 months ago
Hanoi, Vietnam Novo Nordisk Full timeRegulatory Affairs Executive **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Hanoi, Vietnam, VN- In Novo Nordisk Vietnam, the position of Regulatory Affairs (RA) Executive provides you the opportunity to work in a high-performing team to contribute directly towards the business results while creating value for Diabetes patients.**Regulatory...
-
Regulatory Sciences Manager
6 months ago
Hanoi, Vietnam Pfizer Full timeRegulatory Science Manager supports the Head of Regulatory Science, as assigned, to manage all activities pertaining to product registration and other regulatory approvals, including registration plans and submission strategies, local COA for registration (applicable for vaccines), product advertising, drug reports for portfolio in charge including vaccines;...
-
Regulatory Affairs and Safety Head
7 months ago
Hanoi, Vietnam Reckitt Full timeHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...
-
Associate Regulatory Affairs Manager
7 months ago
Hanoi, Vietnam Abbott Laboratories Full time**MAIN PURPOSE OF ROLE** - Product registration including new, renewal, variations, special import license, promotional materials - Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management - Other tasks assigned by the line manager. **MAIN RESPONSIBILITIES** - Contact with DAV, MOH and relevant...
-
Associate Regulatory Affairs Manager
7 months ago
Hanoi, Vietnam Abbott Laboratories Full time**JOB DESCRIPTION**: **MAIN PURPOSE OF ROLE** - Product registration including new, renewal, variations, special import license, promotional materials - Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management - Other tasks assigned by the line manager. **MAIN RESPONSIBILITIES** - Contact with...
-
Senior Regulatory Affairs Executive
6 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...
-
Digital Labeling Manager
7 months ago
Hanoi, Vietnam Pfizer Full timeJOB SUMMARY Is responsible for supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes and associated technical support are also an essential part of the role. JOB RESPONSIBILITIES Supports Labeling Managers by maintaining documentation in...
-
Corporate and Government Affairs Manager
7 months ago
Hanoi, Vietnam Unilever Full time**Job Descriptions**: **External Affairs/Government Relations** - Stakeholder engagement: Build, maintain and enhance relationship with governmental organizations, regulatory bodies, industry associations to build reputation and support business needs. - Policy monitoring & advocacy: monitor changes in laws, regulations, and policies affecting Unilever’s...
-
Associate Medical Affairs Manager
7 months ago
Hanoi, Vietnam Johnson & Johnson Full time**ROLE OVERVIEW** Scientific experts responsible for discussing the Company products, patients’ treatment trends and studies in the therapeutic areas in which the Company is involved. - Jointly responsible for supporting optimal patient outcomes through communication of data, information, knowledge, and insights in support of HCP needs and company...
-
Sr. Specialist, Regulatory Affairs
1 day ago
Hanoi, Vietnam MSD Full time**Job Description**: To ensure timely product registrations that are in compliance with related regulatory requirements. Managing well all projects on registration and maintaining license of products for sporting business. **PRIMARY ACTIVITIES** **_ (_**_ - Weight out of 100%)_ - Notify regulatory authorities of changes to medicines. - Maintain the...
-
Giám đốc Chuỗi Cung ứng
7 months ago
Hanoi, Vietnam Talentnet Full time**RESPONSIBILITIES**: - **Government Affairs Strategy**: Develop and implement a comprehensive government affairs strategy to ensure alignment with the company's business objectives and regulatory requirements. - **Public Relations Management**: Lead public relations initiatives to enhance the company's image and reputation, fostering positive relationships...
-
Specialist Regulatory Affairs
5 days ago
Hanoi, Vietnam MSD Full time**Job Description**: **_ (_**_ - Weight out of 100%)_ - Maintain the process for updating label based on requirement of Global for responsible products - Assist in the monitoring of PV system if any. - Assist for Product quality control together with SCM team if any. **_ (_**_ - Weight out of 100%)_ - Obtain regulatory approval within optimum timelines and...
-
General Affairs
7 months ago
Hanoi, Vietnam Talentnet Full time$2,200 - $2,200 **RESPONSIBILITIES**: - Lead and manage the GA and HR department, providing strategic direction and oversight to ensure alignment with organizational goals and objectives. - Develop and implement departmental strategies, policies, and initiatives to optimize operational efficiency, employee engagement, and organizational effectiveness. -...
-
Associate Commercial
1 day ago
Hanoi, Vietnam Abbott Laboratories Full time**1, Summary**: Quality System implementation at the local EPD Commercial site and assures that quality related matters associated with products commercially distributed including those from Local TPM conform to current Good Manufacturing Practices (cGMP), Abbott Quality standards, and other applicable regulatory standards. **2, Core job...
-
Government Affairs Manager
6 months ago
Hanoi, Vietnam Talentnet Full time$1,900 - $1,900 - Hi-Tech & IT **RESPONSIBILITIES**: - Understand the company's business strategies, build a business ecosystem in the local country or region, and take responsibility for improving the business environment and managing key issues in the local country or region. - Establish sound communication channels with relevant government agencies,...