Regulatory Affairs Officer

2 weeks ago

Hanoi, Vietnam B. Braun Vietnam Co. Ltd. Full time

B. Braun Vietnam, a subsidiary of B. Braun Melsungen AG Group - one of the world's leading manufacturers of medical devices and pharmaceutical products and services - now operates one of the largest medical complex in Vietnam and has become a prestigious trademark in Vietnam healthcare market. With more than 1,400 employees nationwide, we develop high quality “made in Vietnam” products, especially our infusion solutions, dialysis solutions and plastic medical instruments have widely been used and appreciated in international and domestic markets. 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. Let’s become a part of the B. Braun family and share your expertise.

**Duties and responsibilities**:

- To provide regulatory support in the registration of pharmaceutical and medical devices in B.Braun Vietnam.
- This includes to:

- Manage to ensure validity of all above certificates/licenses
- Assist in requesting of label, IFU, samples, test reports and raw data from production.
- Coordinate registration orders for 3rd party manufacturers (if any)
- Update relevant depts as well as Regional/Global RA for newest updated concerned legal requirements.
- Provide administrative support within the functional scope.
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

**Professional competencies**:

- University graduated, major in Pharmacy or Chemistry
- Having experience & good knowledge in registration activities
- Working experiences in 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.

**Personal competencies**:

- 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 we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Benefits**:

- Responsibility Allowance
- Meal Allowance
- Personal Accident and Medical Insurances
- 13th bonus
- Annual bonus
- Public holiday bonus
- Seniority Bonus
- Service Award

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