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Vietnam Regulatory Manager
- Permanent
- Project Manager
- Viet Nam
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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