BD (Becton, Dickinson and Company) Regulatory Affairs Executive in Bangkok, Thailand
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 and OTA countries.
-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)
Degree in Pharmaceutical/Science/Biomedical or equivalent
Minimum 2 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)
Primary Work Location
THA Bangkok - The Offices at Central World
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.