Regulatory Affair Manager - Hanoi

Job 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

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