Regulatory Affairs Manager
3 days ago
**Site Name**: Vietnam - Hanoi
**Posted Date**: Dec 10 2024
**Job Purpose**
To support business objectives in efficient ways and in compliance with local legislation. Reporting to Head of Regulatory Manager, Regulatory Affairs Manager will play a critical role in developing and implementing plan and working procedure of the department.
**Key Responsibilities**:
- ** Planning and managing registration of assigned products**
- To ensure that all new products are registered within the timeframe upon the launching schedule of commercial.
- To ensure that renewals of the existing products are obtained timely for the supply continuity.
- To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation.
- To ensure that all labelling updates are submitted and approved within the Target Submission Category (TSC) and aligned with the global prescription information.
- ** Regulatory consultation**: To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory environment to line manager, other functional departments, above country.
- ** Risk management**: Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives.
- ** Process improvements**: Continuously review and make the appropriate changes in order to improve the internal and cross-functional process.
- ** QMS compliance and GSK policies.**
- ** Responsible to follow up at DAV**for all submitted dossiers by the whole team, to ensure these dossiers are trackable and are reviewed in timely manner at DAV_._
- ** Others**: Perform other tasks relating to Regulatory activities assigned by line manager
**Educational Background**
Bachelor
**Area of Specialisation**
Pharmaceutical Science
**Job-Related Experience**
At least 3 years of experience in Regulatory Affairs field for multinational company, GMP registration, Price registration, import license registration and experience in following up with DAV.
- LI-GSK
**Why GSK?**
**Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
**Important notice to Employment businesses/ Agencies
-
Regulatory Affairs Specialist
2 days ago
Hà Nội, Vietnam Bayer Full time**Job Main Purpose**: In country Regulatory Affairs to support Bayer Radiology Vietnam business, focused on medical devices. **YOUR ROLE & RESPONSIBILITIES**: - With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for Vietnam registrations for Bayer Radiology medical devices. - Provide regulatory responses to local...
-
Hà Nội, Vietnam Standard Chartered Full time**Key responsibilities and capabilities**: **Overview**: - Collaborate effectively across GPRA to align on policy, regulatory, and thematic priorities. - Demonstrate a successful track record of operating in a partnership style within a complex, global matrix organization, focusing on designing and implementing engagement strategies. - Monitor and track...
-
Regulatory Engineer
3 weeks ago
Hà Nội, Vietnam Dell Full timeJoin us as a Regulatory Engineer on our Global Product Compliance Engineering and Environment Affair team in Hanoi, Vietnam to do the best work of your career and make a profound social impact. **What you’ll achieve** An opening based in Vietnam (Hanoi) for Engineer of Global Regulations/Standards and Environmental Affairs is available. The primary...
-
Hà Nội, Vietnam Công Ty TNHH Chuyển Giao Công Nghệ Và Dịch Vụ Y Tế (mtts) Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) About the Role: We are seeking a qualified PRRC to join our team and oversee technical documentation for CE marking under the Medical Device Regulation (MDR). This role will involve managing and maintaining the regulatory documentation for multiple Class IIa and IIb medical devices, ensuring ongoing...
-
Regulatory Affairs Specialist
3 weeks ago
Hà Nội, Vietnam Genedrift Full timeEnsuring necessary compliance with HA, local laws / authorities, for Drugs, Medical Devices, Cosmetics and Food/ Health Supplements Preparation, Review and Compilation of dossiers for submissions to HA, both offline / online, and following up for status of dossiers / supplements. Represent clients for all matters relating registrations and audits and...
-
Regulatory Compliance Specialist
3 weeks ago
Hà Nội, Vietnam Standard Chartered Full time**Job Summary** - The roles serve primarily as a regulatory compliance risk specialist in CFCC Governance team with key responsibility for support in monitoring of regulatory regulation development then cascading to relevant stakeholders for implementation to ensure the compliance with local regulations and the effectiveness of the 2LOD/1LOD’s existing...
-
Department of Home Affairs
2 weeks ago
Hà Nội, Vietnam Australian Government Full timeFull-Time, Non-Ongoing - Hanoi, Vietnam **About the Department of Home Affairs** The Department of Home Affairs is a central policy agency, providing coordinated strategy and policy leadership for Australia's national and transport security, federal law enforcement, criminal justice, cyber security, border, immigration, multicultural affairs, emergency...
-
Expert, Government Affairs
2 weeks ago
Hà Nội, Vietnam Techcombank Full time4 Oct 2024**Expert, Government Affairs (40000197)**: - Category: Corporate Affairs Division- Job Type: - Facility: Legal & Compliance**Job Purpose**: - The job holder consults and implements Operations Management activities in Government Affairs Segment **Key Accountabilities (1)**: - 1. Consult and maintain effective relationships with external partners...
-
Regulatory Licensing Coordinator
2 weeks ago
Hà Nội, Vietnam Tether Operations Limited Full timeCreated in 2014 by pioneering Bitcoin enthusiasts, Tether USDt was the first stablecoin in existence. Tether is disrupting the legacy financial system by offering a more modern approach to money. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future, and we make a significant contribution to a more...
-
Department of Foreign Affairs and Trade
3 weeks ago
Hà Nội, Vietnam Australian Government Full timeFull Time, Non-Ongoing - VND 37,023,003 to VND 41,669,718 - Hanoi, Vietnam **About the Australian Government’s Department of Foreign Affairs & Trade** The role of the Department of Foreign Affairs and Trade (DFAT) is to advance the interests of Australia and Australians internationally. This involves strengthening Australia’s security, enhancing...
-
Hà Nội, Vietnam CÔNG TY L&A Full time**Office Admin (Corporate Affairs Assistant)** - **Mức lương: 8 - 9 triệu + pc** - **Văn phòng**:Tầng 1,2 Tòa nhà Hapulico Complex, 01 Nguyễn Huy Tưởng, Q.Thanh Xuân, Hà Nội. - **Làm việc**:T2 - T6 --- - #**CÔNG VIỆC**: - Gửi thông báo về việc tổ chức các buổi hội thảo, tập huấn, tọa đàm,. - Thực...
-
Senior Associate
1 day ago
Hà Nội, Vietnam The Asia Group Full timeThe Asia Group (“TAG”) is a strategic and capital advisory firm that positions clients - ranging from Fortune 100 multinationals to innovative startups - for success in established and emerging markets across the Indo-Pacific region. Our diverse team possesses decades of government and private sector experience with a work ethos that emphasizes teamwork,...
-
Administration Department Manager
3 weeks ago
Hà Nội, Vietnam The Hong Kong Inclusion Platform Full time**Job Requirements**: - Minimum of 10 years of relevant administration management experience in garment manufacturing factories. - Higher Diploma or above is required. - Experience in managing government foreign affairs. - Proficient in written and spoken Cantonese, English, Mandarin, and Vietnamese. - Mature, independent, proactive, responsible, and...
-
Senior Officer, Financial Crime Compliance
3 days ago
Hà Nội, Vietnam Techcombank Full time14 Oct 2024**Senior Officer, Financial Crime Compliance Surveillance and Investigation (40001526)**: - Category: Corporate Affairs Division- Job Type: - Facility: Legal & Compliance**Job Purpose**: Executing surveillance and investigation, analyzing and reporting suspicious transactions and other types of reports to the authorities as assigned to ensure...
-
Associate - Southeast Asia (Hanoi)
1 day ago
Hà Nội, Vietnam The Asia Group Full timeThe Asia Group (“TAG”) is a strategic and capital advisory firm that positions clients - ranging from Fortune 100 multinationals to innovative startups - for success in established and emerging markets across the Indo-Pacific region. Our diverse team possesses decades of government and private sector experience with a work ethos that emphasizes teamwork,...
-
Senior External Affairs Officer
2 weeks ago
Hà Nội, Vietnam IFC Systems Corporation Full time**Senior External Affairs Officer** **Job #**: - req29713**Organization**: - World Bank**Sector**: - Communications**Grade**: - GG**Term Duration**: - 3 years 0 months**Recruitment Type**: - Local Recruitment**Location**: - Hanoi,Viet Nam**Required Language(s)**: - English**Preferred Language(s)**: **Closing Date**: - 10/18/2024 (MM/DD/YYYY) at...
-
Deputy Legal Manager
2 days ago
Hà Nội, Vietnam Apollo Junior Full time**Job Description**: **Deputy Legal Manager - Safeguard & Drive Business Compliance** Are you a **proactive legal expert** who thrives in a **fast-paced business environment**? Do you have the **confidence to manage high-stakes legal matters**and ensure full compliance with regulations? **Join us and take the lead in shaping our legal strategy!** **Key...
-
Administrative Legal Manager(Real Estate)
2 days ago
Hà Nội, Vietnam Công Ty TNHH Reeracoen Việt Nam Full time**Mô tả công việc**: (Mức lương: 40 - 55 triệu VNĐ) One of the most famous construction and real estate developer in Japan, is looking for a "Administrative cum Legal Manager". This company serves as a link between the head office in Japan and each group company in Vietnam. Then, various projects are outsourced from this company to each group...
-
Senior Manager, Data Engineering
2 weeks ago
Hà Nội, Vietnam Techcombank Full time22 Jan 2025 **Senior Manager, Data Engineering (40000059)**: - Category: Data And Analytics Division - Job Type: - Facility: Data & Analytics **Job Purpose**: - The job holder responsible for: - Leads team to design and develop programs, algorithms and automated processes to cleanse, integrate and evaluate large datasets from disparate sources and...
-
Operation Manager
3 weeks ago
Hà Nội, Vietnam Vina Group Full time**Operational Management**: - Lead and oversee daily company operations to ensure alignment with overall business strategy and objectives. - Develop and implement operational policies and procedures to optimize processes and improve efficiency. - Drive continuous improvement efforts to enhance operational effectiveness and cost control. **Human Resource...