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Regulatory Affair Manager - Hanoi

Hanoi, Vietnam Fixed Term Date posted 10/07/2024
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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 sanofi.com!

#LI-SEA

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