Regulatory Affairs Manager

• Location: Hanoi, Vietnam
• Job Type: Fulltime Permanent

About the Job

As Regulatory Affairs Manager, you will play a critical role in driving timely and compliant product registrations across Sanofi’s portfolio in Vietnam. You’ll lead regulatory strategies and implementation to support business objectives while ensuring adherence to local and global regulatory standards. This role provides a unique opportunity to collaborate with both internal cross-functional teams and external stakeholders, contributing to policy shaping and fostering a compliant, innovative driven regulatory environment.

At Sanofi, our united and dynamic Vietnam Regulatory Affairs team is part of the Southeast Asia & India MCO. Our mission is to be a strategic business partner and an influencing leader in the industry. We foster a Thoughtful Risk-Taking mindset and DAI methodology to enhance operational efficiency while promoting Bionic Regulatory — leveraging data and technology to enable smarter, faster decisions and better patient outcomes.

Main Responsibilities

• Ensure submission and approval of assigned products within optimal timelines, in line with business plans and strategies.
• Manage end-to-end registration processes, including new product filings, renewals, and variations to maintain valid and compliant licenses.
• Maintain labeling and packaging materials in accordance with local regulations and corporate standards.
• Define and execute local registration strategies for responsible products.
• Ensure achievement of regulatory compliance KPIs.
• Review promotional and communication materials for regulatory compliance and provide expert consultation.
• Manage site registration and related RA projects assigned.
• Lead external engagement by developing and maintaining strong relationships with regulatory authorities and key industry stakeholders.
• Proactively monitor, analyze, and communicate regulatory changes and advocate for company interests through policy shaping activities.
• Collaborate with the RA Head to develop long-term regulatory strategies that align with Sanofi’s business vision and priorities.

About You

• Experience: Proven ability to manage a regulatory portfolio independently. Minimum 7 years of experience in vaccine registration is preferred, including collaboration with health authorities at both operational and managerial levels.
• Soft Skills: Strong communication and influencing skills, ability to build trust and manage cross-functional relationships, strategic and analytical thinking, business acumen, and adaptability to digital tools and AI-driven processes.
• Technical Skills: In-depth understanding of regulatory requirements, CMC, ASEAN/ICH-CTD, and WHO guidelines; proficiency in Microsoft Excel and Power BI preferred.
• Education: Bachelor’s degree in pharmacy or related discipline.
• Languages: Fluent in Vietnamese and English (spoken and written).

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether through promotion or lateral movement, locally or internationally.
• Enjoy a thoughtfully designed rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with comprehensive health and wellbeing benefits, including at least 14 weeks of gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas, and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.