Officer - Regulatory Affairs

About The Position
At B. Braun, we are committed to protecting and improving the health of people around the world. As a global healthcare company, we combine innovation, quality, and regulatory excellence to ensure our products meet the highest standards of safety and compliance.
We are looking for a Regulatory Affairs (RA) Officer to join our Regulatory Affairs team. In this role, you will support product registration and regulatory activities for the Nutrition & Healthcare (NUT-HC) portfolio, working closely with internal stakeholders, health authorities, and global teams to ensure products are registered, maintained, and imported in compliance with local regulations.
📍 Cat Linh, Hanoi
Key responsibilities
Update regulation/ internal process of local HA regarding registration activities: Cooperate with local marketing to get confirmation on registration needs and request required documents for registration. Assess dispatched documents, and prepare dossiers for submission. Submission of the registration dossier, follow up and submit supplement dossier if any to get approval.
Request, prepare, submit, and follow up variation dossiers as change management
Update regulation/ internal process of local HA regarding registration activities: Understand clearly all the current regulations regarding product registration including medical devices and biocides, and update and implement new regulations if any. Understand all internal processes of local HA (DAV,IMDA) regarding evaluation activities of registration. update and adapt timely. Update and share with the team and relevant department for implementation
Cross-function support including tender support and collaboration with SCM for the importation of registered products: Provide and order required documents as per LSM request for tender.
Coordinate with LSM, and SCM for the importation of registered products, and provide legal or technical documents to them for their process.
AW development: Do artwork development after getting approval for product registration for production. Do keep informing SCM of the progress of the AW development implementation timeline for placing orders and any changes if any
Requirements
Pharmacist or Chemical bachelor, 1-2 years of RA experience (pharma), working in MNC or RA experience of medical device product is a plus
Having experience & good knowledge in registration activities. Working experiences in both Pharmaceutical & Medical companies are preferable
Good relationship with the authorities related to registration task is preferable. Good knowledge and understanding of concerned legal requirement related to product registration for medicinal, medical devices, supplement and infection control products as well as company operational registration
Good at English both verbal and written.
Strong verbal and interpersonal skills.
Customer-service oriented. Self-motivated, requires little direction. Careful, honest, high sense of responsibility. Able to work on multiple priorities simultaneously. Able to follow directions and pay attention to details and deadlines.
Computer literacy, proficient in Microsoft Office Software
What sets B. Braun apart?
B.
Braun
Vietnam, a subsidiary of one of the world's leading healthcare technology companies, B.
Braun
Melsungen AG Group, now operates one of the largest medical complexes in Vietnam and has become a prestigious trademark in Vietnam healthcare market. With more than 1,400 employees nationwide and proud to be one of 'Best Companies to Work for' in Asia, we develop high quality "made in Vietnam" products widely being used and appreciated in international and domestic market. Our product offering ranges from hospital consumables to high-tech medical devices and equipment.
Every service provided by B.
Braun
Vietnam incorporates the entirety of our knowledge and skills, the company's deep understanding of users' needs and extensive expertise. Our mission is to PROTECT and IMPROVE the health of people around the world. We welcome you to join the B. Braun family and share your expertise!
What can we offer you?
Competitive salary and attractive annual bonus
Production incentive (relevant for production departments)
Guaranteed 13th month salary
Company health insurance
Responsibility allowance
Service award
Company canteen or lunch allowance
Exciting company engagement activities
What's next?
Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you'll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary!
We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here
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Braun Group
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Braun Group
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Braun
Vietnam just click here