Senior Regulatory Affairs

2 weeks ago


Ho Chi Minh City, Vietnam công ty tnhh minthacare Full time

Scope of Responsibilities
Line Manager:
Line 3 : Country Manager
Line 1 : Legal Supervisor
Line 2 : Operation Manager

Main duty:
Co
- ordinate and main handling for inspections/ post
- inspection related to company’s regulatory activités.
changing, updating information products), advertising contents/ marketing materials registration, promotion registration,
Following
- up and working closely with Brands to keep updating all changes related to products for taking needful action on time.
In charge of all regulatory tasks such as registration product notification (include register new,
Handle on license for circulation of medical equipment, license to qualify for medical equipment business and other needful licenses related to the company&039;s regulatory activities.

Main tasks:
Regulatory

Responsible for databases, processes, and systems to manage and maintain all regulatory documents needed (PIF dossiers, LOA, CFS, trademark, advertising registration, sub
- label, barcode,) for regulatory compliance.
Strictly following
- up and updating with Brands for all new changes/ updating relating to products and taking needful action steps with authorities & internal team on time.
Build relationships with MOH and governmental organizations who might help for a better process and support.
Preparing, drafting the official letter, announcement to customers/ partners/ e
- commerce platforms/ so
- commerce on any changes on products such as main label, packaging, barcode,
Monitoring & updating new regulations and its impact on company activities. Ensure all products marketed in Vietnam complies with applicable laws.
Responsible for preparing and submitting dossiers for other activities related to products’ regulatory (i.e. sub
- label, barcode, approval for contents of advertisements, promotion,).
Coordinate with importer and Brands to update any news/ changes related to products after importation.
In charge of preparing dossiers for company products, including but not limited to products, medical devices and other products that company distributes registration, product declaration, modification, notification,... and submitting to competent authorities (MOH, DA,).
Researching the new/ needful regulation relating to business investment plans as assigned.
Coordinate with other departments to provide them with the products’ documentation when necessary.
regulatory activities such as license for circulation of medical equipment, license to qualify for medical equipment business,to distribute company products into the market.

Reporting and other tasks:
Coordinating and main handling with state agencies to serve inspections/ post
- inspections related to the company regulatory activities.
Providing line managers a full report of regulatory matters and tasks.
Other tasks assigned by line managers.
Preparing periodical and/ or ad
- hoc reports to competent authorities

**Yêu cầu công việc**:
Having at least 4 years of experience.
Proactive, good communication, time management, independent, responsible, polite and responsive.
You have strong experience in regulation, especially in the cosmetic & medical device industry.
Familiarity with regulatory rules and regulations of the MOH/DA/. and know how to keep connecting with related authorities.

Sharing Company values:
Adhere and pass on human values: commitment, enthusiasm, positivity, respect for colleagues
Medical and scientific expertise of products and brands
Protect the interest of the company.
Keep information confidential
and manager.
Adhere and pass on the company and brand values: team spirit, colleague support, technical value as Biology, dermatology, aesthetics.
Commitment to the development of the company by providing suggestions and taking initiative.

**Quyền lợi**:

- Đào tạo
- Chế độ bảo hiểm
- Chăm sóc sức khỏe
- Laptop
- Du Lịch
- Chế độ thưởng
- Nghỉ phép năm
- Tăng lương

Cập nhật gần đây lúc:

- 2024-02-03 00:40:27



  • Ho Chi Minh City, Ho Chi Minh, Vietnam Thermo Fisher Scientific Full time

    The Senior RA Specialist will provide expertise to help optimize and accelerate product registrations in Vietnam). The position is part of the APAC Regional Regulatory Affairs team, supporting the Specialty Diagnostics Group within Thermo Fisher Scientific. The position contributes to the growth in the region, by driving the right strategic decisions for...


  • Ho Chi Minh City, Vietnam Chemicals Conglomerate (Revealed Later) Full time

    **Overview**: Our client is a leading multinational Fortune 500 company with offices scattered throughout the APAC region. They take on some of the world’s most meaningful challenges, delivering critical insights and innovative solutions to help their customers achieve clean water, safe food, abundant energy, and healthy environments. If your goals...


  • Ho Chi Minh City, Vietnam findtalent s clients Full time

    Xem và nộp hồ sơ ngay **Lưu ý**: - Người tìm việc đang xem tin **Regulatory Affairs Specialist**: - **Mã tin đăng: 3373959**. Mọi thông tin liên quan tới tin tuyển dụng này là do người đăng tin đăng tải và chịu trách nhiệm. Chúng tôi luôn cố gắng để có chất lượng thông tin tốt nhất, nhưng...


  • Ho Chi Minh City, Vietnam TẬP ĐOÀN Y KHOA HOÀN MỸ Full time

    Quay lại trang tìm kiếm 2 tuần trước **REGULATORY AFFAIRS DIRECTOR**: Ứng tuyển ngay Vị trí TP. HCM Lương Thỏa thuận Công ty Tập đoàn Y khoa Hoàn Mỹ Phòng ban GCEO’s Office Loại hình Full time **JOB SUMMARY**: The Regulatory Affairs Director will work alongside the HMC Group legal and compliance team and reports...


  • Ho Chi Minh City, Vietnam Công Ty TNHH Qualtech Consulting Corporation Full time

    **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...

  • Regulatory Affairs

    2 weeks ago


    Ho Chi Minh City, Vietnam Manpower VN Full time

    **Work Location**: D4 HCMC **Work Time**: Monday - Friday (8h-17h) **Salary**: Negotiable The main purpose of a Regulatory Affairs (RA) Contractor is support RA-related duties of Consumer RA (cosmetic, pharmaceutical drug) that assigned by managers, support business goes smoothly. - Studying scientific and legal documents to check they meet legal...


  • Ho Chi Minh City, Vietnam Công Ty TNHH Luxasia Việt Nam Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) To manage registration and compliance matters for global brands according to Vietnam’s regulation. Principal Accountabilities Main responsibilities: - Manage the processes to notify DAV or to obtain regulatory approvals for new / existing products within the identified timeframes - Manage the...


  • Ho Chi Minh City, Ho Chi Minh, Vietnam Unilever Full time

    JOB PURPOSEThe role of Regulatory Affairs is to grow BU Unilever's competitiveness through a proactive Regulatory function that assures compliance, creates external space for innovation, drives external Advocacy on new regulations.The job holder leads the regulatory strategy and guidance for the innovation projects of Personal Care categories in Vietnam for...


  • Ho Chi Minh City, Vietnam Prudential plc Full time

    Prudential’s purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support...


  • Ho Chi Minh City, Ho Chi Minh, Vietnam Prudential plc Full time

    Prudential's purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support our...


  • Ho Chi Minh City, Ho Chi Minh, Vietnam Công Ty TNHH Luxasia Việt Nam Full time

    Mô tả công việc:(Mức lương: Thỏa thuận) To manage registration and compliance matters for global brands according to Vietnam's regulation.Principal AccountabilitiesMain responsibilities: Manage the processes to notify DAV or to obtain regulatory approvals for new / existing products within the identified timeframes Manage the internal database...


  • Ho Chi Minh City, Vietnam Công Ty Cổ Phần Thương Mại Việt Nữ Full time

    **Mô tả công việc**: (Mức lương: Đến 14 triệu VNĐ) - Products registrations: submit new, renew and follow-up of all registration documents for all products: cosmetics, food supplements, medical devices and drugs. - Be proactive to suggest and find solutions when confronted to regulatory affairs issues - Collaborate with authorities in a smart...


  • Ho Chi Minh City, Vietnam Văn Phòng Đại Diện Nibblen Life Sciences Private Limited Tại Thành Phố Hồ Chí Minh Full time

    **Mô tả công việc**: (Mức lương: 8 - 25 triệu VNĐ) - Prepare Registration dossier for new products, renewal, extension in comply with MOH’s regulations and Regulatory plan - Handle regulatory administrative tasks - Support Marketing & Market access teams in submission and following up related dossiers with MOH - Updated with latest Laws and...


  • Ho Chi Minh City, Vietnam Văn Phòng Đại Diện Nibblen Life Sciences Private Limited Tại Thành Phố Hồ Chí Minh Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) - Prepare Registration dossier for new products, renewal, extension in comply with MOH’s regulations and Regulatory plan - Handle regulatory administrative tasks - Support Marketing & Market access teams in submission and following up related dossiers with MOH - Build and maintain good relationship...


  • Ho Chi Minh City, Vietnam DKSH Full time

    **Location**:Ho Chi Minh, VN, VN**Job Function**:Client and Customer Services**Requisition Number**:143826**Description**: **Job Summary** - Manage and archive PV documents and RA/PV SOPs **General Responsibilities** **Pharmacovigilance** - Assume back-up role in the absence of PV main contact - Receive, follow up Safety reporting case - Prepare Safety...


  • Ho Chi Minh City, Vietnam quốc tế instruments Full time

    Regulatory and Compliance Duties- To provide timely progress reports and budgeting information to Senior Manager, QRA. - Perform product registration, renewals and amendments for all new and existing products including Medical Devices, Radioactive Products, Pharmaceuticals, Poison Drugs etc. and ensure compliance to regulatory authorities’ requirements. -...


  • Ho Chi Minh City, Ho Chi Minh, Vietnam Zoetis Full time

    Job summary: Support on In-country oversight for quality affiliated ( Product released, Investigation, Complaint handling, Logistics Service Providers).Job description: Approval of SAP Item Master Data in- country Oversight of incountry testing laboratoreis on importation Incountry product released and communicate quality issue to Supply Chain Quality....


  • Ho Chi Minh City, Ho Chi Minh, Vietnam quốc tế instruments Full time

    Regulatory and Compliance Duties- To provide timely progress reports and budgeting information to Senior Manager, QRA. Perform product registration, renewals and amendments for all new and existing products including Medical Devices, Radioactive Products, Pharmaceuticals, Poison Drugs etc. and ensure compliance to regulatory authorities' requirements. Handle...


  • Ho Chi Minh City, Vietnam Page Group Vietnam Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận)The Regulatory Affairs Specialist will own their desk of product compliance and provide knowledge of local regulation to internal and external stakeholders. The position will report directly to regional manager and collaborate with regional team to support customers across Southeast Asia. Technical...


  • Ho Chi Minh City, Ho Chi Minh, Vietnam Văn Phòng Đại Diện Nibblen Life Sciences Private Limited Tại Thành Phố Hồ Chí Minh Full time

    Mô tả công việc:(Mức lương: triệu VNĐ) Prepare Registration dossier for new products, renewal, extension in comply with MOH's regulations and Regulatory plan Handle regulatory administrative tasks Support Marketing & Market access teams in submission and following up related dossiers with MOH Updated with latest Laws and regulations of Vietnam...