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Regulatory Affair Manager - Hanoi
Hanoi, Vietnam Fixed Term Date posted Aug. 21, 2024Job title:Regulatory Affairs Manager - Hanoi
Location: Hanoi
About the job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
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.
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
#LI-SEA
Pursue progress. Discover extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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