Nguyen Thi Linh has nearly 15 years’ experience as Regulatory Advisor. Linh joined the firm as an associate in the Hanoi office in 2018. Linh is a senior-level professional with deep expertise in navigating the complex regulatory landscape for a wide range of products, including cosmetics, pharmaceuticals, medical devices, and dietary supplements in Vietnam. She plays a pivotal role in ensuring client products comply with Vietnamese and international regulations, facilitating successful market entry and ongoing compliance.

Joining with her are other senior attorneys from KENFOX, making an efficient regulatory team, who has successfully assisted a diverse array of pharmaceuticals, medical devices, cosmetics, and dietary supplements. Our achievements span products sourced from top manufacturers across the globe, including Korea, Thailand, China, Germany, Spain, the Netherlands, New Zealand, USA, United Kingdom, Romania, France, and Italy.

Core Responsibilities:

Strategic regulatory guidance:

• Client consultation: Provide comprehensive advice to clients globally on all aspects of regulatory affairs, from initial product development to post-market surveillance.

• Regulatory strategy: Develop tailored regulatory strategies that optimize product registration timelines and minimize compliance risks, taking into account specific product categories and target markets.

• Risk assessment: Identify and assess potential regulatory hurdles, proactively addressing them to mitigate delays and ensure successful product launches.

Dossier preparation and submission:

• Document compilation: Lead the preparation of comprehensive product registration dossiers, ensuring they meet the stringent requirements of the relevant regulatory authorities.

• Quality assurance: Rigorously review all dossier components for accuracy, completeness, and adherence to regulatory guidelines.

• Submission coordination: Manage the timely submission of dossiers to competent authorities, including electronic and physical submissions.

Regulatory liaison and follow-up:

• Authority interaction: Establish and maintain strong working relationships with regulatory authorities in Vietnam.

• Query resolution: Proactively address any questions or concerns raised by regulatory authorities during the review process.

• Approval tracking: Closely monitor the progress of product registration applications, ensuring timely approvals and resolving any unexpected delays.

• Post-market support: Provide ongoing regulatory support to clients, including assistance with product variations, renewals, and adverse event reporting.

Leadership and business development:

• Team management: Oversee a team of regulatory affairs professionals, providing mentorship, guidance, and fostering a culture of excellence.

• Business growth: Actively participate in business development activities, identifying new client opportunities and expanding the firm’s regulatory services portfolio.

• Industry engagement: Stay abreast of evolving regulatory landscapes, participating in industry conferences and forums to maintain a leading edge in regulatory knowledge.

Additional skills and qualifications:

• Education: Advanced degree in pharmacy.

• Experience: Extensive experience in regulatory affairs, ideally within a consulting or industry setting. Proven track record of successful product registrations.

• Regulatory knowledge: In-depth knowledge of Vietnamese and international regulatory requirements for cosmetics, pharmaceuticals, medical devices, and dietary supplements.

• Communication: Excellent communication skills, both written and verbal, with the ability to effectively communicate complex regulatory information to diverse audiences.

• Project management: Strong project management skills, with the ability to manage multiple projects simultaneously and meet tight deadlines.