Regulatory Affair Specialist

4 weeks ago

Hanoi, Vietnam AstraZeneca Full time

**Regulatory Affair Specialist - HN**

**About AstraZeneca and AstraZeneca Vietnam**

AstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines. At AstraZeneca, science and patients are at the heart of everything we do. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Established in 1994, AstraZeneca Vietnam has come a long way in 27 years of advancing Vietnam's healthcare. We change lives through innovative science with $25mil in R&D investment (2020 - 2024); 40 ongoing clinical trials with 2800+ patients; 44 partnered hospitals and 14 medicines involved in trials. We have built strong public-private partnerships for sustainability and healthcare access through many programs and activities such as Healthy Lung, Young Health Program, Careme, Giá Như, Health System Sustainability & Resilience, Green Energy for Health, Response to Covid-19.

We have gained some recognition for our efforts from the Minister of Health's Certificates of Merits for outstanding contributions to advancing cancer treatment (2019) and exceptional contributions to Vietnam’s fight against COVID-19 (2020); BritCham 2021 Awards for Contributions to healthcare and 25+ years of service in Vietnam; Ho Chi Minh Communist Youth Union’s Medal and Certificate of Merit for contributions to youths (2021); Excellent Leadership - Visionary Leader Award (2021); HR Excellence - Workplace Culture Award (2021) and Vietnam's Top 100 Places to Work Award (2018 - 2020).

**What you’ll do**:
**Job Description / Capsule**

To implement regulatory strategies to gain rapid and high quality approvals and ensure high standard of regulatory compliance, in order to achieve the company’s business objectives.

**Typical Accountabilities**

**Drug registration and promotional material registration**
- Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy.
- Develop and implement the milestones plan of drug registration
- Develop artwork required for packaging to secure new product launching and secure stock for sales
- Provide detailed information on regulatory status of affected products and advise on appropriate regulatory processes.
- Prepare promotional material submission in line with local regulation, update status to cross-functional team in due time, negotiate effectively to protect claims

**2. External activities**
- Initiate, build up and maintain the external relationships with regulatory authorities to achieve regulatory outcomes.
- Actively collect all relevant regulatory information and update regulatory environment on time to cross-functional team, Global team.

**3. Others**
- Provide qualified regulatory documents, response to DAV/ hospitals questions supporting for tender in due time
- Manage efficiently matters related to Regulatory on stock-related issues and communicate with relevant cross-functional team in time; no stock shortage
- Provide comments on draft regulations.

**Education, Qualifications, Skills and Experience**

**Essential**
- University graduation in Pharmacy or Medicine.
- Good command in English skills.
- Knowledge of Pharmacy products development process and have strong knowledge and understanding of local regulatory requirements and processes.
- Proactive and highly committed to support and deliver results.
- High Sense of Ownership and accountability for achievement.
- Highly organized and self-disciplined.
- Good interpersonal skills - capable of working and relating with senior authorities.
- High level of integrity and good morals.
- Analytical skills.
- Self-motivated and good team player.

**Desirable**
- Working experience at least 3 years in Regulatory Affairs Department.

**Key Relationships to reach solutions**

**Internal (to AZ or team)**

Marketing, Sales, KA, Logistics, Medical, Clinical, Global Product Teams, International Regulatory Affairs, Manufacturing Sites and QA, Regional Office, HR, Finance, Corporate Affairs Teams.

**External (to AZ)**

Hospitals and Health Professionals, Regulatory Authorities, Universities, Institutes.

**Why AstraZeneca?**:
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

**What will you get?**:
**So, what’s next?**:
If you are already inspiring yourself to join our dream team, we can’t wait to hear from you.

If you are ready to bring new in

  • Regulatory Affair Specialist

    2 weeks ago

    Hanoi, Hanoi, Vietnam AstraZeneca Full time

    Regulatory Affair Specialist - HNAbout AstraZeneca and AstraZeneca VietnamAstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines. At AstraZeneca, science and patients are at the heart of everything we do. Based in Cambridge, UK,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Hanoi, Vietnam Công Ty TNHH Persolkelly Việt Nam Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) 1. Regulatory affairs (approximately 10% of time commitment) - Update the local regulation for the company. - Establish working relationships with the internal and external parties (Local Health Services, external fellow RA professionals, market consultants, unofficial industry committees, official...

  • Regulatory Affair

    4 weeks ago

    Hanoi, Vietnam công ty cổ phần medcomtech Full time

    Xem và nộp hồ sơ ngay **Lưu ý**: - Người tìm việc đang xem tin **Regulatory Affair**: - **Mã tin đăng: 3559850**. 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 chúng tôi...

  • Regulatory Affairs Specialist

    3 weeks ago

    Hanoi, Vietnam PERSOLKELLY Vietnam Full time

    **Purpose of Function** - Regulatory affairs and product registration for product license for medical devices and non-medical devices accordance to local laws.**Tasks and Responsibilities** **Regulatory affairs** (approximately 10% of time commitment)- Update the local regulation for the company. - Establish working relationships with the internal and...

  • Regulatory Affairs Executive

    4 weeks ago

    Hanoi, Vietnam Novo Nordisk Full time

    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...

  • Regulatory Affairs

    4 weeks ago

    Hanoi, Hanoi, Vietnam Reckitt Full time

    We are ReckittHome 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...

  • Regulatory Affairs Executive

    2 weeks ago

    Hanoi, Hanoi, Vietnam Novo Nordisk Full time

    Regulatory Affairs ExecutiveCategory:Reg Affairs & Safety PharmacovigilanceLocation: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...

  • Regulatory Affairs Manager

    4 days ago

    Hanoi, Vietnam Novartis Full time

    As Regulatory Affairs Manager, you will ensure of regulatory compliance and achieving registration approval on time from local authority, in line with company’s objectives. Your responsibilities include, but not limited to: - Ensure of assigned product portfolio registration submission and approval on time (new registration including new site, renewal...

  • Regulatory Affairs

    2 weeks ago

    Hanoi, Hanoi, Vietnam Reckitt Full time

    Home 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 Manager

    4 weeks ago

    Hanoi, Vietnam GSK Full time

    **Site Name**: Vietnam - Hanoi **Posted Date**: Jun 4 2024 Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you. As Regulatory Affairs Management Professional you will be...

  • Regulatory Affair Executive

    3 weeks ago

    Hanoi, Vietnam công ty tnhh rv group việt nam Full time

    Xem và nộp hồ sơ ngay **Lưu ý**: - Người tìm việc đang xem tin **REGULATORY AFFAIR EXECUTIVE**: - **Mã tin đăng: 3360222**. 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...

  • Senior Quality

    4 weeks ago

    Hanoi, Vietnam Adecco Full time

    **Responsibilities**: **Integrated System Management (Quality, Occupational Health & Safety, Environmental System)**: - Implement and maintain effective processes to meet IMS objectives, to provide evidence of compliance with relevant quality, occupational health, and safety and environmental (HSE) directives, standards, technical and legislative...

  • Regulatory Affairs Manager

    2 weeks ago

    Hanoi, Hanoi, Vietnam Novartis Full time

    As Regulatory Affairs Manager, you will ensure of regulatory compliance and achieving registration approval on time from local authority, in line with company's objectives.Your responsibilities include, but not limited to:Ensure of assigned product portfolio registration submission and approval on time (new registration including new site, renewal...

  • Regulatory Affairs Manager

    2 weeks ago

    Hanoi, Hanoi, Vietnam GSK Full time

    Site Name: Vietnam - HanoiPosted Date: Jun 4 2024Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.As Regulatory Affairs Management Professional you will be responsible for the...

  • Regulatory Affairs Manager

    2 weeks ago

    Hanoi, Vietnam PERSOLKELLY Vietnam Full time

    Location: 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...

  • Senior Regulatory Affairs Manager

    4 weeks ago

    Hanoi, Vietnam Adecco Full time

    **Job summary**: A newly created Regulatory Affairs Manager has just arisen in one of the top MNC company in consumer healthcare sector. This Regulatory Affairs Manager position will report to Head of RA and is responsible for providing regulatory guidance in the area of product/ label registration and product promotion/advertising to navigate safely...

  • Regulatory Affairs cum Admin

    4 weeks ago

    Hanoi, Hanoi, Vietnam RGF HR Agent Recruitment Full time

    Confirm food ingredient information for new products Confirm that prohibited raw materials are not mixed in. Perform permit application procedures for unapproved ingredients and foods Gather information necessary for the application, collaboration with Japan HQ side Follow the regulatory application process Collaborate and support other back office teams....

  • Senior Regulatory Affairs Manager

    2 weeks ago

    Hanoi, Hanoi, Vietnam Adecco Full time

    Job summary:A newly created Regulatory Affairs Manager has just arisen in one of the top MNC company in consumer healthcare sector.This Regulatory Affairs Manager position will report to Head of RA and is responsible for providing regulatory guidance in the area of product/ label registration and product promotion/advertising to navigate safely through...

  • Regulatory Affairs Department Manager

    1 week 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...

  • Regulatory Affairs

    2 months ago

    Hanoi, Vietnam Abbott Laboratories Full time

    **JOB DESCRIPTION**: - Primary Function: - A Regulatory Specialist who, working with little or no supervision, applies scientific knowledge, experience and ingenuity to register new product, renew licenses, file change notification, variation at Ministry of Health. Core Job Responsibilities: - Follow up the validity of licenses of Abbott’s products. -...