Skip to main content
Two women in white lab coats look at a computer screen together

Regulatory Affair Manager - Hanoi

Hanoi, Vietnam Fixed Term Date posted 10/07/2024
Apply now

Job title: Regulatory Affairs Manager - Hanoi

  • Hiring Manager: Nguyen Lan Huong
  • Location: Hanoi
  • % Remote working and % of travel expected: 40% remote working and 20% travelling
  • Job type: Permanent

About the job

Our Team:

An united and dynamic Vietnam regulatory team is a part of SOUTH EAST ASIA & INDIA MCO. Our mission is to be a business partner and strategic partner of the agencies & influencing leader in the industry. We foster Thoughtful Risk Taking mindset and DAI methodology for efficiency operation and promote for Bionic Regulatory where unleash the power of data and technology to enable better decision intelligence and outcomes.

Main responsibilities:

Regulatory management & implementation

  • Ensure the submission and approval of assigned products in optimal timeline, aligning with Business plan and strategies:
  • Ensure to file new product registration and update the current registration file in timely manner.
  • Renew and revise the existing product license to ensure all are valid and compliance with regulation.
  • Maintain currency of labeling, pack leaflets in accordance with local regulations and corporate data sheet.
  • Set up the local registration strategy/plan for responsible products.
  • Ensure regulatory compliance KPIs.
  • Handle promotional materials and provide consultant from regulatory aspects.
  • Site registrations
  • Other assigned RA projects & perform other duties as assigned by management.

Policy shaping & External Engagement

  • Understand business strategies and develop appropriate stakeholders mapping/solution and implement action plans to effectively manage and accelerate registration approval.
  • Develop and facilitate relationships with key Regulatory Authorities and decision-makers; discuss and challenge issues and negotiate solutions in the best interests of the company.
  • Proactively analyse, comment, and communicate any changes in the regulatory environment to related functions.
  • Actively involve and contribute to policy shaping.

About you

  • Experience: management of a portfolio independently, at least 5 years’ experience in vaccines registration is preferable, working with Health Authorities at both execution and management level.
  • Soft skills: Team collaboration, Communication/Influence skills, Ability to work in a matrix environment, Business acumen and customer orientation, High standards of integrity, Ability to develop strong networks and influence internal and external stakeholders, Problem Solving skill, Strategic thinking and planning.
  • Technical skills: Expert knowledge of regulations and regulatory requirements, understand local regulatory environment; understand CMC, ASEAN/ICH-CTD, WHO’s guidelines…; excellent in excel & power BI is a preferable
  • Education: Bachelor’s degree in Pharmaceutical
  • Languages: Fluent spoken and written in Vietnamese & English

Sanofi Behaviors and Skills

This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, People Leadership (if applicable), Relationship and Influence.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at!


Apply Now
  • You have not viewed any jobs yet.

  • You have not saved any jobs yet.

Man at whiteboard pointing to presentation and looking at coworker

our talent

We believe better is out there – and that extends to how we support people. Our People Strategy prioritizes inclusivity, transparency, and efficiency in talent development. It’s allowed us to chart personalized plans to keep employees and managers on the same page when it comes to training and succession planning. From upskilling to mentorship, we prepare our teams with the resources they need to pursue progress.

Illustration of map pins on globe

Find out more about this location

Experience possibility

  • Your Saved Jobs

    Learn more
  • Cambridge Crossing

    We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.

    Learn more
  • Innovation in Action

    Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.

    Learn more
  • Sustainable and Green

    Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.

    Learn more
  • Sanofi’s AI Centre of Excellence in Toronto

    The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.

    Learn more
  • Ama

    Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.

    Learn more
  • Sanofi Canada's Philanthropic Efforts

    By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.

    Learn more
  • Emmanuel

    Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.

    Learn more
  • Dimitrije

    Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.

    Learn more
  • Ziv

    Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.

    Learn more
  • When you grow, we all grow

    We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.

    Learn more
  • Build a career with purpose

    Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.

    Learn more
  • Bolder, better futures

    Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.

    Learn more
  • Our locations

    We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.

    Learn more
  • Sanofi Stories

    At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.

    Learn more
  • Sanofi at Cambridge Crossing

    Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.

    Learn more
  • Why Sanofi

    Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.

    Learn more
  • Our people & culture

    We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.

    Learn more
  • Sanofi's Postdoctoral Program

    Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.

    Learn more
  • Physician Careers at Sanofi

    At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.

    Learn more
  • AI Centre of Excellence

    The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.

    Learn more
Two women, seated in an office lobby, working on laptops and talking

What could we achieve together?

Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.

What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.