Job Title:  Regulatory Affairs Assistant Manager

Short Description

Job Responsibilities:

The Assistant Manager - Regulatory Affairs will be responsible for the registration/market access process (regulatory affairs) so that product launch scheules are met, quality management system establishment and maintenance, customer satisfaction is achieved including compliance with the applicable legislations, organization's policy, and standard operating procedures (SOPs). 

• Create, compile, and manage the regulatory filing for the product registration, license retention, variation application, and advertisement application to the relevant authorities in the designated country to allow “as early as possible” market access and complying with local legislations. Maintain the Dealer Licenses of the Organizations for Business Support.
• Establish and maintain GDPMD Quality Management System (QMS) as requested by the Thailand FDA with the support from regional RA team. It includes but not limited to coordinating with other cross-functional teams for SOP crea.tion/ revision, conducting QMS audit and management review, providing necessary training and document and records control others.
• Participate in post market surveillance activities. Perform post market regulatory reporting, corrective actions (e.g. adverse event and FSCA) and assist in product recall if any.
• Monitor and report the regulation update and RA registration status in a timely manner. Provide advice to internal and external teams in interpreting relevant guidance documents and standards, assess the risk impact and propose countermeasures for regulatory compliance.
• Maintain effective communication and proactively coordinate with HQ and Regional RA team, cross-functional teams, authorities to drive RA activities for compliance and business support. Train the RA counterpart if necessary.    
• Creating and maintaining tracking process and reporting tools for all QA/RA tasks, including registration submissions, approvals, projects and tender requested
• Provide regulatory expertise to support the RA enquiries and participate in and/or support various teams and projects to define regulatory requirements as required. Other ad-hoc duties as assigned by the management.

Job Requirements:

• Bachelor’s Degree in pharmacy, medical device, biology, or related field
• 4 - 7 years experience in regulatory affairs for medical devices
• At least 4 to 7 years’ experience in product, business processes / procedures, regulatory frameworks, and QMS for Medical Devices
• Proficient in the English & local language, both written and verbal
• Good knowledge of Microsoft Office (Word, Excel, PowerPoint)
• Proficiency in MS office suite
• Travelling Requirements: As required