Vietnam Regulatory Manager job in Ho Chi Minh City, Vietnam

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First Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Project Manager

Location: Viet Nam

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Vietnam Regulatory Manager to join a pharmaceutical organisation. This role is on a permanent basis and is located in Ho Chi Minh City.

Responsibilities:

Guide DAV engagement and meetings with DAV for the allocated projects when needed.
Serve as the main RA responsible person who is accountable for end-to-end registration actions and application process for all products registered in Vietnam.
Guarantee that both electronic and paper regulatory reports archives are organised and upheld rendering to internal SOPs.
Discuss the regulatory methods, proposal plans and timelines, as well as impact assessments of trends, guidelines and alterations for all Vietnam products.
Raise any possible compliance and business risks, as well as be accountable in taking suitable corrective measures/mitigation plans, in consultation and agreement with line management.
You will both own and handle the regulatory timelines to guarantee proposal-approvals in a timely manner.
The ideal candidate will serve as a business partner to the business development team in assessment of registration potential for new portfolio/products expansion, which is included in due diligence assessments.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a pharmacy field.
At least 10+ years of experience in regulatory and industry for medicinal product and medical device registration.
A background in DAV registrations with expertise in quality assurance and pharmacovigilance per local needs.
Business insight with comprehension of local regulatory and business landscapes.
Works well independently with the ability to resolve issues.
Works well within a fast pace, multidisciplinary matrix setting.
Results focused with a sense of urgency.
Able to handle various projects concurrently.
Capable of thinking tactically and translate methodical directives into strategical initiatives.
Communication skills both verbally and in writing.
Fluency in the English language.
Leadership abilities.

If you are having difficulty in applying or if you have any questions, please contact Mandy Fang at +65 3159 1467.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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