日本と海外をつなぐクラウドソーシング

Value-Rx, Inc.

Regulatory Affairs Specialist

2016/03～ 2014/03

• Ensuring that the company's products comply with the regulations of the Food and Drug Administration
• Keeping abreast of international legislation and guidelines
• Preparing submissions of license variations and renewals
• Monitoring and setting timelines for license variations and renewal approvals
• Maintenance of licenses/authorizations for existing marketing authorizations
• Develop and execute regulatory plans for complex projects including new products
• Drafting of product labels and patient information leaflets
• Providing strategic advice to senior management throughout the development of a new product
• Undertaking and managing regulatory inspections
• Reviewing company practices and providing advice on changes to standard operating procedures
• Liaising with regulatory authorities
• Specifying storage, labeling and packaging requirements

Terumo Marketing Philippines, Inc.

Regulatory Affairs Associate

2012/08～ 2013/11

• Liaison officer between the company and relevant government regulatory agencies
• Prepare, evaluate, and file product registration documents (initial, renewal, amendment, exemption, and compliance) to be submitted to Food and Drug Administration and Department of Health
• Responsible for the timely renewal of registered products and licenses for medical device
• Provide bidding documents and regulatory support to Sales and Marketing Department
• Maintain a good file of original documents such as company licenses, certificates of product registration, and certificates from factories and diplomatic officials
• Maintain up-to-date knowledge on international and domestic regulatory requirements

Fresenius Kabi Philippines, Inc.

Regulatory Affairs Officer

2017/09～ 2019/02

Regulatory Affairs (responsible for drugs, medical devices, and food products):
• Acts as a liaison between the company and regulatory offices
• Coordinate with Regional and Global Regulatory Affairs for strategic, ethical, efficient, and prompt compliance to local regulatory requirements
• Review, analyze, prepare, and assemble regulatory documents for new products/projects of all product groups according to current regulatory regulations (e.g. ASEAN Common Technical Documents/Requirements, ASEAN Common Submission Dossier Template and ASEAN Variation Guidelines, national guidelines)
• Arrange electronic copies of NDAs per global system (KIPDIPS)
• Monitor and facilitate in-process regulatory agency submissions
• Handle submission to FDA of all post-approval variations
• Coordinate, implement strategies, and observe ethical standards for prompt renewal and acquisition of required permits, licenses, clearances, and other regulatory requirements
• Prepare design and format in Philippines-specific packaging materials per Generic Law requirements
• Maintain corporate regulatory database (KabiRegtrack) for product life cycle of all registrations including post-approval changes
• Provide support to sales team on bidding requirements and formulary inclusions of hospitals
• Provide support to quality assurance activities by coordinating on the repackaging activity including development of local sticker overlay instruction for local labeling compliance
• Monitor regulatory agency and industry changes, trends, and requirements to contribute effectively to product development and product strategies

Deputy National Safety Officer:
• Assist the National Safety Officer (NSO) to establish and maintain a local PV System, including management of related documentation and out-of-office availability
• Act as support to the NSO in Overseeing Patient Support Programs (PSP) initiated by the company and ensure compliance according to Global System
• Coordinate in handling and reporting of safety related issues in accordance with the national laws and corporate guidelines
• Secondary user of COSI Database System (Communication of Safety Information)
• Coordinate with the NSO on the submission of periodic reports to the local health authorities
• Provide support in training and updates on the regulations and processes to field (e.g. Medical Sales Representatives) and non-field (e.g. office-based) personnel on a regular basis
• Checking of websites of the local health authorities for safety relevant information and participate in their training programs
• Keeping and maintenance of PV and regulatory related documents and records

FUJIFILM Philippines Inc.

Regulatory Affairs Officer

2019/03～

• Ensuring the company’s products comply with the regulations of FDA Philippines
• Keeping up to date with local and international legislation and guidelines
• Collecting, collating, and evaluating scientific data relevant to company’s products.
• Developing and writing clear arguments and explanations for new product licenses and license renewals
• Preparing submissions of license variations and renewals to strict deadlines
• Monitoring and setting timelines for license variations and renewal approvals
• Advising management and manufacturers on regulatory requirements
• Providing strategic advice to management as necessary, relevant to company’s product registration process
• Undertaking and managing regulatory inspections
• Reviewing company practices and providing advice on changes to systems
• Liaising with and making presentations to regulatory authorities
• Negotiating with regulatory authorities for marketing authorization
• Specifying storage, labelling, and packaging requirements
• Liaises to respective agencies on the processing import permits
• Liaise with Product Marketing Manager on all Medical Marketing related activities, events, conventions, and workshops