Role: Senior Manager, Regulatory Affairs
Location: Vietnam
Duration: Permanent
Rate: Negotiable
About the Position
An exciting opportunity has arisen for an experienced Senior Manager in Regulatory Affairs to oversee regulatory compliance for therapeutic products in Vietnam. This role involves developing strategic regulatory plans, managing submission strategies for product registration, and overseeing regulatory aspects throughout the product lifecycle, from development to post-approval.
Key Responsibilities
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Act as the licensed pharmacist and license holder for the local affiliate in Vietnam.
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Ensure successful registration of new products while maintaining compliance with product safety activities.
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Manage and oversee all relevant maintenance activities, including lifecycle management strategies.
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Collaborate effectively with internal teams and external bodies to achieve business objectives.
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Provide expert regulatory input into strategic decision-making, including portfolio reviews and external communications.
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Prepare, submit, and support clinical trial applications.
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Establish regulatory priorities, budgets, and allocate resources effectively.
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Develop and maintain standard operating procedures and local working practices.
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Formulate and implement regulatory affairs policies to ensure ongoing compliance.
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Stay up to date with relevant regulations, including proposed and final regulatory changes.
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Support new product launches and provide assistance during Health Authority and business partner audits.
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Supervise and mentor Regulatory Affairs Associates and Managers as required.
Qualifications & Experience
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Expertise in Vietnam’s drug regulatory legislation and requirements.
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Minimum of 6 years of experience in the biotechnology or pharmaceutical industry, with at least 6 years in Vietnam Regulatory Affairs.
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Regulatory experience in other Southeast Asian countries is an advantage.
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Background in oncology or specialty care medicines is preferred.
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Strong ability to collaborate and build consensus across functions.
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Skilled at influencing cross-functional teams, including engagement with internal and external stakeholders.
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Excellent interpersonal, oral, and written communication skills.
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Fluency in English, both written and spoken.
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Proven track record of mentoring and developing team members.
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Experience in challenging existing processes to drive improvement.
This role presents an excellent opportunity for a regulatory affairs professional seeking to lead and shape the compliance landscape in Vietnam. If you have the expertise and strategic mindset to drive regulatory success, we encourage you to apply.