Regulatory Affairs Executive

**Job Description Summary**:
We are **the makers of possible**

BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

**Why Join Us?**

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a **maker of possible**with us

Responsible for all regulatory activities for products to be registered/marketed in the country which includes:

- Work closely with related stakeholders from the various BUs to determine which products need to be included for registration. Support to follow up with BURA for eIPRRA approval.
- Work with BURA to obtain all required information/documents for registration purpose.
- Compile documentation and ensure completeness and quality of registration dossiers.
- Submit registration dossiers and follow through until approvals are obtained.
- Review the changes, assess the impacts and provide support for registration activities due to changes (NoC/ACR). Work closely with related stakeholders for the submission until getting approvals.
- Support any post-market field action reporting to local MOH (if applicable)
- Support to check advertising materials, declare the contents of Ad. Mat based on regulations.
- Support tenders with regulatory documents/information.
- Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
- Updates and maintain all the trackers & systems related to regulatory activities.
- Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
- Provides periodic Regulatory Updates to the business
- Provide regulatory inputs for and participate in internal and external audits where appropriate.
- Build a good relationship with in-country junior regulators at the least.
- Undertake additional projects and tasks as assigned by the supervising manager.

**Preferred Requirements**
- Graduated from Medical University or University of Pharmacy
- Interpersonal skills and good team player
- Meticulous and results-oriented
- Must be able to work independently with minimum supervision
- Multinational background will be advantageous
- Good communication skill in English
- Having network with Vietnam MOH will be advantageous

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

**Required Skills**:
Optional Skills


**Primary Work Location**: VNM Hanoi City

**Additional Locations**:
**Work Shift**: