130 Inspection Manager jobs in Vietnam

Regulatory 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 Affairs**
- Primary responsible for Regulatory Affairs - to coordinate the product registration, extension, renewal, variations to health authorities etc. activities in Novo Nordisk in Vietnam.- Interact with Vietnam health authorities to obtain new and extension licenses for importing and marketing Novo Nordisk products, conduct technical and commercial discussions with concerned authorities and address queries, review labeling updates, represent company interests during external presentations, influence government decisions in order to ensure compliance to applicable business norms and policies and protect company interests, receive and review news and update regulations in Vietnam.
- Co-ordinate with necessary departments including corporate RA, trademark, patent departments and BASEA RA for regulatory submission, approval and maintenance of product licences in support of NOVO NORDISK Vietnam affiliate business needs.
- Prepare dossiers for regulatory new/extension registration submission and submit to HA in support of NOVO NORDISK Vietnam affiliate business needs.
- Regulatory review of promotional materials.
- Prepare dossiers and submit, follow up to get approval for promotional material where required and drug variation with Drug Advertisement and Information Department at DA Vietnam.
- Maintain master file and PV tracker by updating regularly with accuracy information.
- Maintain and update information of Novo Nordisk regulatory systems such as VaultRIMS, LIFT or any other systems as required by HQ/BA.
- Monitor and update local external requirements within the affiliate.
- Regulatory compliance to local internal and external requirements in Vietnam.
- Maintenance of Drug import, drug selling and Medical devices import licenses by ensuring extension and variation approvals within required timelines.
- Initiation/approval of country-specific labeling and handling of printed packaging materials and ensuring strict compliance to the local labeling requirements. Perform proofreading the country specific packaging to make sure in compliance and accuracy.

**Qualifications**
- Bachelor’s Degree in Pharmacy, Life Sciences and related disciplines- 1-2 years experience in Regulatory- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.- #LI-AMS1

**Mô tả công việc**:
(Mức lương: 4 - 9 triệu VNĐ)
**Introduction**

Qualtech is an Asia Medical Device Consulting and Clinical Trial (CRO) Company with branch offices in China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Vietnam, Thailand, Korea, USA and Germany. We are looking for a Talented Regulatory Affairs Intern who is fluent in English and be able to understand to medical device regulations in the countries we service for. Qualtech is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people.

**Job description**
- Oversight of regulatory submissions for assigned projects/countries, which may include completion of submissions or notifications, as required.
- Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
- Investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
- Other duties as assigned.

**Chức vụ**: Thực Tập Sinh

**Hình thức làm việc**: Bán thời gian

**Quyền lợi được hưởng**:
**Benefits**
- Allowance: The hourly rate ranges from VND 40,000 to 50,000, depending on ability.
- Confirmation of completing the internship.
- Have chances to become a full-time employee.
- Professional, dynamic working environment.

**Yêu cầu bằng cấp (tối thiểu)**: Đại Học

**Yêu cầu công việc**:
**Requirements**:

- Can work at least 24 hours per week for a duration of 4 months to 6 months.
- Fresh graduates for senior students in related majors, such as biomedical engineering, biotechnology, pharmaceutical.
- Ability to manage multiple projects, set priorities to meet deadlines.
- Keeping attention to details.
- Strong interpersonal skills, in written and oral.
- Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.

**Yêu cầu giới tính**: Nữ

**Ngành nghề**: Công Nghệ Sinh Học,Hành chính Văn phòng,Hóa Học/Hóa Chất,Y Tế

Đại Học
Không yêu cầu

**Requistion ID** : 80589
Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
**Position Summary:**
Supports regulatory affairs activities for medical device licenses in Vietnam.Manages requests for and strategically plan work related to registration activities in Vietnam. Manages projects and/or regulatory affairs for the assigned Location(s)/Region(s).
**Key Responsibilities**
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices
+ Leads and manages regulatory submissions
+ Manage communications with authorities on behalf of the company for market access related submissions
+ Reviews and interprets regulatory requirements and guidance documents to ensure compliance
+ Coordinates regulatory activities with internal teams and external regulatory agencies
+ Review and approve product labelling
+ Stays current with regulatory requirements and updates affecting medical devices
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships
+ Complies with company and departmental policies and administrative requirements
+ Performs other duties as assigned or as needed
**Typical Background**
**Education:**
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
**Language:**
+ Fluent in written, reading, spoken and listening English.
+ Fluent in written, reading and spoken Vietnamese
**Years and Type of Experience:**
+ 5(+) years of experience in Vietnam regulatory affairs, preferably in the medical device industry
+ Knowledge of Vietnamese Regulations and classifications
+ Knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR)
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
**Required Computer / Software Skills:**
+ Proficiency with Microsoft Office Suite
**Key Required Skills, Knowledge, and Capabilities:**
+ Strong leadership, project management, and organizational skills, including attention to detail
+ Excellent communication (both written and verbal) and interpersonal skills
+ Ability to work effectively in a team environment, as well as independently
+ Willingness to learn and adapt to new processes and technologies
**Key Leadership Behaviors**
+ Actively articulates and promotes Dentsply Sirona's vision and direction
+ Advocates on behalf of the customer
+ Values driven with an insistence on excellence
+ Promotes high performance, innovation, and continual improvement
+ Consistently meets Company standards, ethics, and compliance requirements
+ Strong results orientation and analytical skills
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise
+ Resolves conflicts and fosters a positive working environment
+ Be a change leader
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.

Our client, a renowned pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team based in Phan Thiet, Binh Thuan, VN . This role is critical for ensuring compliance with all national and international pharmaceutical regulations, facilitating the smooth approval and lifecycle management of medicinal products. You will play a key role in preparing and submitting regulatory dossiers, interacting with health authorities, and providing expert regulatory guidance throughout the product development process.

Key Responsibilities:

• Prepare, review, and submit regulatory documentation for drug product registrations, variations, and renewals to health authorities.
• Ensure all regulatory submissions are accurate, complete, and adhere to current guidelines and standards.
• Develop and implement regulatory strategies for new product development and lifecycle management.
• Liaise with national and international regulatory agencies, responding to queries and facilitating communication.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Provide regulatory guidance and support to internal teams, including R&D, manufacturing, quality assurance, and marketing.
• Review promotional materials and product labeling for regulatory compliance.
• Manage post-approval regulatory activities, such as annual reports and safety updates.
• Conduct regulatory due diligence for potential business development opportunities and partnerships.
• Maintain up-to-date knowledge of pharmaceutical regulations, guidelines, and best practices.

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of drug development processes and regulatory submission requirements in key markets.
• Proven experience in preparing and submitting CTD (Common Technical Document) or equivalent dossiers.
• Familiarity with relevant regulatory guidelines (e.g., ICH, FDA, EMA, local regulatory authority guidelines).
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Ability to work effectively both independently and as part of a collaborative team.
• Proficiency in regulatory information management systems and databases.
• Experience in specific therapeutic areas is a plus.

This position requires your presence at our office in Phan Thiet, Binh Thuan, Vietnam. We offer a competitive compensation package and the opportunity to grow within a dynamic pharmaceutical environment.

Our client, a globally recognized pharmaceutical company dedicated to advancing healthcare solutions, is actively seeking a meticulous and experienced Remote Pharmaceutical Regulatory Affairs Specialist. This position is vital for ensuring compliance with global regulatory requirements for drug development and market authorization. As a remote employee, you will play a key role in preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance throughout the product lifecycle. Your responsibilities will include developing regulatory strategies for new drug applications (NDAs), managing post-approval changes, and monitoring evolving regulatory landscapes in key markets. You will also be responsible for ensuring that all company activities related to pharmaceutical product registration and maintenance meet the highest standards of compliance. Collaboration with cross-functional teams, including R&D, clinical operations, and quality assurance, is paramount. This fully remote role requires a Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline, complemented by a minimum of 4 years of direct experience in pharmaceutical regulatory affairs. A deep understanding of ICH guidelines, FDA, EMA, and other major regulatory agency requirements is essential. Excellent written and verbal communication skills, meticulous attention to detail, and strong project management capabilities are required. Experience with regulatory information management systems is a plus. If you are a dedicated regulatory professional passionate about bringing life-saving medicines to patients worldwide, this remote opportunity offers a platform to make a significant impact.

Our client is seeking an experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their international team. This is a fully remote position, ideal for professionals who thrive in a flexible work environment and possess a strong command of global pharmaceutical regulations. You will be responsible for preparing, submitting, and managing regulatory filings for new drug applications (NDAs), variations, and annual reports in various international markets. Your role will involve interpreting and applying regulatory guidelines from agencies such as the FDA, EMA, and other health authorities to ensure compliance throughout the product lifecycle. You will liaise with regulatory agencies, respond to queries, and support regulatory inspections. Key responsibilities include developing regulatory strategies, assessing the regulatory impact of changes, and ensuring that all promotional materials and labeling comply with regulations. The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field, with at least 5 years of direct experience in pharmaceutical regulatory affairs. A thorough understanding of drug development processes and regulatory submission requirements is essential. Strong written and verbal communication skills, meticulous attention to detail, and the ability to manage multiple projects simultaneously are crucial. Experience with regulatory information management (RIM) systems is highly preferred. This role demands an organized, proactive, and detail-oriented individual capable of navigating complex regulatory landscapes from a remote setting. This is an outstanding opportunity to contribute to bringing life-saving medicines to patients worldwide.

Our client , a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist. This role is crucial for ensuring compliance with all relevant health authority regulations during drug development and lifecycle management. You will be responsible for preparing and submitting regulatory dossiers, responding to health authority queries, and staying abreast of evolving regulatory landscapes.

Key responsibilities include developing regulatory strategies for new product submissions, managing post-approval changes, and ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). You will liaise with internal departments, external partners, and regulatory agencies worldwide. The ideal candidate will possess a strong understanding of drug development processes, regulatory submission requirements in key markets, and have excellent scientific, written, and verbal communication skills.

We are looking for a detail-oriented individual with strong analytical and problem-solving abilities. Experience with electronic submission formats and regulatory databases is expected. This position offers a hybrid work arrangement, requiring occasional attendance at our facility in Thanh Hoa, Thanh Hoa, VN . Your expertise will be vital in accelerating the approval process for new and existing pharmaceutical products, contributing to patient access to innovative treatments. Join a dedicated team focused on advancing healthcare through rigorous regulatory compliance.

**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 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.

**JOB REQUIREMENTS**:
**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

**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