Senior Regulatory Affairs Executive

3 days ago

กรงเทพมหานคร, Thailand BD Full time

**Job Description Summary**: To ensure all BD products with new MDR and IVDR labeling comply with all relevant local pre/post-market requirements for the country. Registration submission to support product registration in Thailand.

**Who We Are**

**Main Responsibilities**

Responsible for all activities associated with regulatory clearance for all products in the country which includes:

- Work closely with the Business Leads from the various BU to determine which products need to be included for registration
- Work with BD division RA (BURA) to obtain necessary information / documents (e.g. CFG / CFS, etc.)
- Compile documentation and ensure completeness and quality of registration dossier
- Submit registration dossier and follow through until regulatory clearance is obtained (if applicable)
- Review and Prepare change notifications or amendments of registered products for submission
- Submit change notifications or amendments of registered products (if required)
- Maintain and update list of registered products in the applicable platforms (e.g. SharePoint, RA Shared folders, RIM etc.)
- Support any post-market field action reporting to local MOH (if applicable)
- Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
- Updates and maintain In-Country Registration Submission Tracker and Planner and other local requirements as deemed appropriate.
- Responsible to review and provide impact assessments for any changes to products. (e.g. change in packaging and labeling)
- Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
- Undertake additional projects and tasks as assigned by the supervising manager
- Provide regulatory inputs for and participate in GDP audits where appropriate
- Build a good relationship with in-country junior regulators at the least (where appropriate)

**Our Requirements**
- Degree in Pharmaceutical/Science/Biomedical or equivalent
- Minimum 5 years of working experience in a function related to regulatory or quality, preferably in the healthcare industry.
- Knowledge of quality systems or regulatory requirements preferably related to medical devices.
- Good team player
- Have good problem-solving acumen
- Independent, meticulous and communicates well
- Proficient in Microsoft Office (Word, PowerPoint, Excel)

**Culture and Benefits**

Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

**How To Apply**

**Primary Work Location**: THA Bangkok - The Offices at Central World

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

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