Regulatory Affairs Manager at Sanofi Aventis US LLC

Hà Nội, , Vietnam -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Communication Skills, Analytical Thinking, Business Acumen, Relationship Management, Strategic Thinking, Adaptability, Technical Knowledge

Industry

Pharmaceutical Manufacturing

Description

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. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

Ensure timely submission and approval of product registrations while managing end-to-end registration processes. Collaborate with internal teams and external stakeholders to maintain compliance with regulatory standards.