Officer - Regulatory Affairs

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

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

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