Director

Job Description : Regulatory Affairs Director to lead their team in Vietnam. This role offers an exciting opportunity to create and implement strategic plans that align with business goals and ensuring successful execution. You will be the key liaison with both national and international agencies, resolving regulatory issues and accelerating product approvals. Your excellent interpersonal, communication, and negotiation skills will be crucial in representing the company. Lead both long-term and short-term planning for regulatory activities. Manage and guide the regulatory team to ensure successful execution. Work closely with internal and external stakeholders to resolve regulatory issues. As a Regulatory Affairs Director, you will play a pivotal role in leading both long-term and short-term planning for regulatory activities. You will manage the regulatory team, ensuring successful program execution while working closely with internal and external stakeholders. Your responsibilities will include developing strategies to achieve regulatory goals, overseeing product registration applications, collaborating with local partners for compliance, managing reports for registered products, and monitoring government policies. Develop and implement strategies and engagement plans to achieve regulatory goals. Review and respond to regulatory inquiries related to product registrations. Oversee the preparation and submission of product registration applications. Collaborate with local partners and QA team to ensure compliance with local regulations. Manage reports, renewals, and updates for registered products. Monitor government policies, analyzing their impact on business opportunities. The ideal candidate for the Regulatory Affairs Director position brings a wealth of experience in the pharmaceutical industry's regulatory affairs. With a Bachelor’s or Master’s degree in pharmacy or medicine, you have developed an in-depth understanding of Vietnam’s regulations, guidelines, and regulatory processes. Your strong relationships with the Drug Administration of Vietnam (DAV) demonstrate your ability to navigate local authorities effectively. Your proven leadership skills are complemented by an entrepreneurial mindset focused on growth. Bachelor’s or Master’s degree in pharmacy/ doctor with substantial experience in regulatory affairs within the pharmaceutical industry. In-depth knowledge of Vietnam’s regulations, guidelines, and regulatory processes. Strong relationships with the Drug Administration of Vietnam (DAV) and experience dealing with local authorities. Proven leadership skills with an entrepreneurial mindset focused on growth. Excellent interpersonal, communication, and negotiation skills. Ability to work effectively in a cross-functional and international matrix environment.

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