обновлено 10 дней назад
Executive - Regulatory Affairs (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive - Regulatory Affairs (Pharma): Leading the RA sub-team for the HC portfolio to drive product registration, GMP assessment, and compliance with local health authority requirements. Focus on managing registration dossiers, coordinating with DAV and IMDA, and ensuring regulatory updates are implemented timely.
Location: Onsite in Hanoi, Vietnam
Company
is a global healthcare company dedicated to protecting and improving the health of people worldwide through innovation, efficiency, and sustainability.
What you will do
- Lead the RA sub-team for the HC portfolio, managing task delegation and coaching team members.
- Manage product registration and GMP assessments, including the preparation and submission of registration and variation dossiers.
- Monitor and implement regulatory updates from local health authorities such as IMDA and DAV.
- Coordinate with Sales, Marketing, and SCM to support tender activities and ensure compliant product importation.
- Oversee the development of product artwork following registration approvals.
- Act as the primary point of contact with local Health Authorities for quality management procedures.
Requirements
- Degree in Pharmacy or a related field.
- Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
- At least 2 years of experience working in a multinational corporation (MNC).
- Strong established relationship with the DAV.
- Fluency in English and proficiency in MS Office.
- Must be based in Hanoi, Vietnam.
Nice to have
- Experience in medical device regulatory affairs.
Culture & Benefits
- Work environment based on trust, transparency, and appreciation.
- Focus on professional development and sharing expertise.
- Contribution to global healthcare improvements.
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