Are you a Regulatory Affairs professional passionate about regulatory affairs efficiency? If so, this opportunity could be for you! Join us in Hanoi at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!
As a Officer - Regulatory Affairs at B. Braun you will play a vital role in doing product registration and other relevant regulatory activities for INT - HC porfolio products
Your 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
What you will bring to the team:
- Pharmacist or Chemical bachelor, at least 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
- 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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