Vietnam Regulatory Manager

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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